Unsere Leistungen beruhen auf unserer Unternehmenskultur, die von Respekt, Engagement und Motivation geprägt ist.

Wir sind Valneva

Daniel, Manufacturing Technician in Schottland

Seitdem ich begonnen habe in der Impfstoffproduktion zu arbeiten, konnte ich mir viele Fähigkeiten aneignen. Es ist ein ganz besonderes Gefühl, ein Teil dessen zu sein, was hier passiert.

Vera, Head of Clinical Operations, Lyme Disease Vaccine Development in Österreich

Ich leite ein Team, das für das Management der klinischen Phase-2-Studien für unseren Borreliose-Impfstoff verantwortlich ist. Es ist wirklich spannend, die Entwicklung des Programms zu sehen, und ich bin froh, mit einem so großartigen Team zusammenzuarbeiten.

Michael, Technical Assistant in QC Analytics in Österreich

Ich schätze mich glücklich, dass ich mit meiner Arbeit in der Qualitätskontrolle einen Beitrag zum Kampf gegen die COVID-19-Pandemie leisten kann, denn wir stellen sicher, dass jede Charge des Impfstoffs auf jedem Schritt ihrer Reise getestet wird.

Susanna, Head of Manufacturing Support in Schweden

Ich leite das Projekt der Umstellung von der Produktion des Cholera-Impfstoffs auf die Produktion des Impfstoffkandidaten gegen COVID-19 in Solna. Ich bin wirklich stolz auf die Arbeit, die das Team hier geleistet hat.

Klaudia, Sales Manager Österreich

Valneva ist ein schnelllebiger und vielseitiger Arbeitsplatz, wo man den Enthusiasmus spürt und wirklich etwas bewegen kann. Obwohl alle sehr konzentriert sind, kann man leicht auf Kollegen zugehen, auch über Abteilungs- und Hierarchiegrenzen hinweg.

Melissa, Head of Vaccine Scouting & Technology Evaluation in France

Im Scouting- und Innovationsteam suchen wir nach neuen Impfstoffkandidaten, die Valneva in seine Pipeline aufnehmen könnte. Als Wissenschaftlerin bei Valneva bin ich froh, dass ich mit meiner Arbeit einen Beitrag zur Prävention von Infektionskrankheiten leisten und das Leben von Menschen verbessern kann.

Douglas, Senior Systems Administrator in Schottland

Ganz gleich, ob man in der Forschung, in der Produktion, in der Verwaltung oder im IT-Bereich arbeitet, der Schlüssel zur Zusammenarbeit ist ein konstruktiver und wertschätzender Dialog zwischen Kollegen. Bei Valneva findet man anspruchsvolle Aufgaben, ein multikulturelles Umfeld und ein klares Bekenntnis zu Ethik, Compliance und Integrität.

Robert, Director of Manufacturing Operations in Schweden

Es ist toll, mit den talentierten Menschen bei Valneva in Schweden zusammenzuarbeiten, wo wir derzeit unsere Kapazitäten erweitern, um einen vollständigen Abfüll- und Verpackungsprozess für unseren Impfstoffkandidaten gegen COVID-19 anbieten zu können.

Der Erfolg von Valneva beruht auf dem Engagement und der Kompetenz von mehr als 750 Mitarbeitern. Valneva ist ein internationales Unternehmen, das stolz darauf ist, seinen Mitarbeitern die Möglichkeit zur persönlichen Entwicklung und Entfaltung zu geben und gleichzeitig die Vereinbarkeit von Beruf und Familie zu fördern. Als globales Unternehmen, das alle Kulturen respektiert, sind wir davon überzeugt, dass die große Vielfalt unserer Kollegen uns innovativer, effektiver und wettbewerbsfähiger macht.

Offene Stellen

Logistics & Facilities Coordinator France (Nantes, France)

  • Position: Full time
  • Location: Nantes, France

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Key Responsibilities

Nous recherchons un(e) Technicien(ne) Logistique et Services Généraux en CDI pour renforcer notre équipe basée à Saint-Herblain (Nantes). Sous la direction du Responsable Achats Maintenance et Logistique France, vous assurerez les missions principales suivantes :

+ Assurer la réception des marchandises au quotidien :

  • Réception des marchandises livrées par les transporteurs incluant un contrôle visuel de l’état des colis.
  • Contrôle des marchandises réceptionnées : conformité des références livrées par apport aux commandes, respect des conditions de transport, intégrité des emballages.
  • Réception électronique des bons de livraison sous ERP (AX Dynamics).

+ Assurer la gestion des stocks et des références produits (sous ERP):

  • Gérer l’entrée en stock dans le magasin après réception.
  • Assurer la mise à jour quotidienne de l’état des stocks.
  • Créer les demandes d’achat nécessaires au maintien du stock.
  • Effectuer les sorties de stocks selon les procédures internes.
  • Créer les nouveaux articles non référencés.

+ Assurer les livraisons internes quotidiennes dans les laboratoires conformément aux bons de commande des opérateurs.

+ Assurer le suivi de prestataires externes : Gestion de l’arrivée et du départ des intervenants, accompagnement des prestataires dans le bâtiment et laboratoires.

+ Assurer le suivi de la prestation de bio-décontamination des laboratoires afin de suivre la bonne exécution des prestations demandées.

+ Assurer au quotidien les activités aux laboratoires :

  • Gestion des poubelles DASRI
  • Gestion de la laverie centrale
  • Gestion du rangement des sas et des laboratoires
  • Gestion des vêtements de travail de laboratoire (blouses et pyjamas)

+ Seconder le service de maintenance interne.

+ Réaliser des missions ponctuelles relatives au bon fonctionnement du bâtiment.

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+ Formation Bac à Bac+2 en Logistique avec une expérience d’1 à 2 an(s).

+ Vous maîtrisez la saisie de demandes d’achat, de bons de livraison sous un logiciel de gestion de stocks et commandes (ERP).

+ Vous êtes rigoureux(se) et disposez d’excellentes qualités d’organisation.

+ Vous avez le sens du service client.

+ Vous êtes réactif(ve) et faites preuve d’initiative.

+ Vous êtes familier(e) du respect des procédures et instructions de travail.

+ Maîtrise de l’anglais indispensable.

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Clinical Operations Manager (f/m/d)

  • Position: Full time
  • Location: Vienna, Austria

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Responsible for all aspects of one or more phase 1-4 clinical studies from protocol through clinical study report finalization for regulatory submission.
  • Ensures compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicable.
  • Ensures all operational study deliverables are met according to timelines, budget, operational procedures, and quality standards.
  • Manages CROs and other external partners and ensures adherence to scope of work within timelines and budget.
  • Interacts with other departments and relevant functional areas.

YOUR QUALIFICATIONS

  • Academic education, Master or PhD degree (Life Science)
  • Minimum of 3 years of clinical management experience
  • Profound knowledge of ICH-GCP, data protection laws, clinical trial directive and other regulations and guidelines relevant for the conduct of clinical trials
  • Ideally experience in the field of vaccine development
  • Supervisory/managerial experience in clinical development including supervision of CROs and/ or CRAs is a must
  • Team oriented
  • Excellent communication, presentation, interpersonal, independent problem solving, financial management and leadership skills
  • Organized and independent work style with strong systematic approach to prioritization but still detail oriented
  • Excellent command of English (spoken and written)
  • Excellent computer skills
  • May be required to travel to supervise and coordinate clinical studies

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 60.000,00 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

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Regulatory Affairs Manager (f/m/d)

  • Position: Full time
  • Location: Vienna, Austria

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Coordinate and participate in preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, INDs) to competent authorities worldwide for approved and developmental products
  • Operate electronic submission tools (eCTD manager, validation tools) and electronic Data Management Systems (eDMS) used at Valneva Austria GmbH
  • Develop content, timelines and contingencies for submissions in collaboration with internal and external contributors
  • Ensure that submissions are of high quality, meet all regulatory requirements and are in compliance with corporate goals and directives
  • Provide regulatory feedback in project teams
  • Participate in contacting competent authorities for respective projects/products and interact with internal departments
  • General regulatory and maintenance tasks

YOUR QUALIFICATIONS

  • University degree in science and/or regulatory affairs
  • 4 – 5 years’ experience in Pharmaceutical industry preferably with vaccines
  • 1-2 years experience in Regulatory affairs
  • Experience in Regulatory Life Cycle Management and eCTD is an advantage, although not required
  • Excellent English and German skills
  • Proficiency with standard Windows and Office programs
  • Experience with electronic document management systems and IT knowledge
  • Good social skills and ability to work in teams

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 45.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

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QC Technician (Micro) (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Job Summary

To undertake microbiological tasks and analysis for the release and monitoring of facilities, raw materials, intermediate and final product samples according to defined procedures and protocols, in accordance with regulatory requirements.

Responsibilities:

  • Execute microbiological procedures for testing of raw materials, intermediate products and final product samples, according to defined SOPs and protocols
  • Perform environmental monitoring of cleanroom areas as required, to support manufacturing processes and Facility Contamination Control (FCC)
  • Conduct all activities in a careful and safe manner and in full compliance with HSE requirements
  • Ensure that all required training is complete in procedures performed and operate in compliance with regulatory requirements
  • Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to Line Manager
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
  • Maintain all QC systems, databases, logs and support the generation of QC trend data
  • Be accountable for QC areas being clean, tidy and well organised and in a state of continuous inspection readiness
  • Ensure that equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Undertake any other duties in accordance with company requirements
  • Undertake shift work and/or support activities that require to be performed out of normal business hours, when requested, to support business priorities

Experience:

  • Degree in biological sciences or relevant experience
  • Knowledge of GMP guidelines and regulatory body requirements
  • Experience of microbiological methods in a production-focused environment including but not limited to; Total Viable Count, Bacterial Endotoxin, Environmental monitoring, Microbial Identification and Growth Promotion
  • Minimum of 1 Year relevant Industry Experience
  • Biologics / vaccine background ideal
  • Experience of Quality Management Systems
  • Experience of working to deadlines and managing conflicting priorities
  • Experience managing external relationships for effective delivery, e.g. vendors, test houses

Skills:

  • Ability to organise, deliver planned schedules and work across QC, Process Development and QA
  • Experience of writing QMS documentation, e.g. SOPs, Deviations, Change Controls, CAPA desired
  • Excellent time management and prioritisation skills
  • Ability to communicate at all levels within and outside QC
  • Ability to contribute effectively to successful teamwork, and work independently and manage own workload when required

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Accountant (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Your responsibilities

  • Processing of incoming invoices with Readsoft Online (OCR-tool for importing e-invoices into ExFlow)
  • Preparing & posting invoices within the ERP-System (MS Dynamics AX2012/ExFlow)
  • Close cooperation and communication with the Procurement department regarding PO invoice postings
  • Vendor correspondence (reminders, bank account changes, audit letters & others)
  • Support of testing for ERP modifications
  • Support in IFRS month- and quarter-end closing activities
  • Preparation of various reports and documentation related to SOX
  • Vacation replacement for Accounting Team Members

Your qualifications

 

  • Graduate from a commercial school or bachelor degree (e.g. HAK)
  • At least 2 years of professional experience in Accounting (favorably in an international environment and with ERP-System knowledge)
  • Good knowledge of MS Office, especially Excel, as well as initial experience with AX desirable
  • Very good written and spoken English skills, German is a plus
  • Strong numerical skills, ability to work in a team and precise working style
  • IT and ERP affinity

Our offer

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, combination of home office and office work, performance-related bonus, lunch vouchers, childcare center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 40.000,- gross per year based on full-time employment. However, our salaries are market oriented and in line with your qualifications and experience.

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Buyer (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialise two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

An opportunity has arisen at Valneva Scotland for a Buyer within the SCM Procurement Department.

Job Summary

The Buyer will work in association with their team in ensuring that all materials, equipment and services is procured in line with quality and regulatory expectations, with the most favourable commercial terms and in line with the Company procedures.

Responsibilities

  • End to end procurement, including contract & supplier management
  • Purchase goods, materials and services from approved suppliers and in line with defined Company SOPs and protocols
  • Secure the most favourable terms in regards to cost, quality, guarantee of delivery and continuity of supply
  • Negotiate and improve prices and terms of business with suppliers continuously reviewing opportunities to make tangible savings and improve on commercial terms
  • Manage purchase orders on the company ERP system.
  • Contact suppliers to resolve price, delivery timelines, quality or invoice issues
  • Communicate and monitor any supply and/or service issues which may impact the business operations in a timely manner
  • Work cross functionally and collaboratively to improve the performance of existing suppliers and escalate as appropriate poor performance and alternative routes of supply
  • Ensure that a professional and consistent approach is taken with all internal and external relationships
  • Communicate in a consistent and professional manner
  • Compile data and reports relating to supplier performance and to enable evaluation
  • Ensure training and QMS are up to date in a timely manner.
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience

  • Relevant work experience in a procurement role within a manufacturing environment; experience of working in a GMP environment would be advantageous but not essential
  • Knowledge and experience of working with a quality management system
  • Experience working within a procurement team managing a supply chain with a portfolio of complex products identifying and mitigating areas of risk
  • CIPS knowledge and understanding would be beneficial but not essential
  • Experience of working closely and collaboratively with suppliers
  • Computer literate (Microsoft Office)

Required Skills

  • Team player
  • Able to build and maintain effective a collaborative relationships with internal and external stakeholders
  • Good communication and written skills
  • Commercial awareness with an understanding of how failure impacts the business operation
  • Able to manage time effectively, focus and prioritise critical tasks and to achieve set targets
  • Able to work well under pressure
  • Familiarity with an integrated Enterprise Resource Planning (ERP) system would be beneficial
  • Self-motivated, energetic and value driven
  • Desire to develop and grow as the company expands

For the right candidate there will be training and development opportunities to maximise your ability to succeed in this role and advance your career with Valneva.

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Health and Safety Manager (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

Are you a forward thinker with exceptional leadership skills? Do you have a background as a HS Manager and thrive in getting the best out of the people you work with? If so, we’d love to hear from you!

The Role

We have a wonderful opportunity for a Health & Safety Manager to support our organisational safety strategy, overseeing H&S policies and regulations to ensure they are fully adhered to as we move forward with our vaccine manufacturing. You will continually strive to ensure Valneva meets its statutory obligations in all areas pertaining to health, safety, and welfare at work.

You would be responsible for (but not limited to):

  • Working with and training all employees to manage, monitor and improve the health and safety standards in the workplace
  • Working with the Head of Facility Management to ensure requirements for; Building regulations, fire safety, electrical safety, contractors permit to work systems, Legionella and pressure systems regulations are complied with
  • Ensure that all accidents, incidents and near hits are documented, investigated and recommended improvements implemented
  • Establish a structured health and safety system in compliance with health and safety legislation
  • Keep up to date with all aspects of relevant health, safety & welfare at work legislation and communicate relevant changes to the business
  • Provide regular reports to the Human Resources Director, Executive Management Team and Senior Management Team on relevant health and safety activities

What we’re looking for:

The ideal HSE Manager will come from a STEM background and possess relevant health and safety experience within the biopharmaceutical manufacturing industry or other related industries, as well as a post graduate qualification in Health and Safety (NEBOSH Diploma, NVQ Level 5 Diploma).

Previous line management experience is advantageous. Above all, you will possess exceptional relationship and developmental skills, and will have a track record of promoting a safe working culture within your organisation.

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Engineering Technician (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

We have immediate openings within our Engineering Team to join at Technician Level, with openings for a variety of skillsets including Mechanical, Electrical, Calibration and Validation. These will be 12 hour shift based roles supporting with our 24/7 Manufacturing Schedule

Your role will be to execute defined, trained engineering procedures for maintenance, qualification, validation and calibration of equipment / facility, in compliance with applicable cGMP standards, regulations, techniques, best practice and business metrics.

Responsibilities

  • Maintain safe and available systems through supervision and execution of equipment, plan and facilities maintenance, qualifications, validation and calibration ensuring compliance defined by SOPs, protocols and procedures
  • Apply cGMP / GEP work practices and techniques in compliance with regulatory requirements
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures
  • Collaborate with internal customers ensuring clear communication on planned and unplanned actions ensuring due consideration of access, supervision, documentation, safety product quality or regulatory compliance
  • Be accountable for engineering areas being clean, tidy and well organised and in a state of continuous inspection readiness
  • Maintain engineering records, logs and documentation in a compliant manner
  • Deliver actions required to ensure progression of investigations, deviations, change controls and CAPAs to agreed timescales
  • Conduct all activities in a careful and safe manner and in full compliance with HSE requirements ensuring that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Actively contribute to the development and maintenance of enthusiastic, supportive and collaborative environment within the team setting, identifying areas for continuous improvement to the respective manager
  • Shift work and out of hours work as required
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience

  • HNC/ONC or equivalent experience in relevant engineering discipline
  • Relevant work experience in a GMP environment
  • Experience in GMP document preparation, process execution, recording data and report writing
  • Experience of co-ordinating equipment / facilities maintenance
  • Experience in the management of environmental, health and safety issues, including permits to work
  • Knowledge of Good Engineering Practice and process improvement tools such as six sigma, lean, FMEA etc

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Qualified Person (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

Are you an experienced QP? Or just starting out on your journey, with a good understanding and working knowledge of the Pharmaceutical Industry? We would welcome an opportunity to speak with you further.

With responsibility for performing the legal and routine duties with respect to the review, approval and certification of licensed and investigational products. To maintain effective quality oversight of internal and external contract manufacturing and testing activities in order to verify that local and Global Quality Systems/procedures are defined, being adhered to, are operating effectively and comply with UK, EU, FDA, RoW regulatory requirements.

Our successful Qualified Person would be someone possessing relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment.

Key Responsibilities

  • To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; as defined in article 51 of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and described in Annex 16 of the EU Guide to GMP
  • To represent the company to external authorities on liaison with MHRA, FDA, EMEA CAs and OMCLs on; product defect reporting, recall and Inspection related matters (all interactions must be aligned with Regulatory Affairs)
  • To advise the Director of Quality Operations on any matters arising which impact on supplier or service provider status or the import of bulk product into EU, or release of final product for use in the UK/EU and its export from the EU
  • To manage the batch disposition process, comprising batch document review and approval and batch certification file compilation. Make quality assessments on released products subject to temperature excursions and communicate to customers
  • To ensure the systems and processes for the management of Product Technical Complaints and Product Recalls are being conducted in accordance with the licensed risk management and pharmacovigilance systems
  • To act as Livingston site representative for Product Safety Review Board. Escalation of relevant issues to and from committee meetings/Global Quality Focus Groups
  • To assist with the preparation, review and approval of technical / quality agreements for suppliers and service providers
  • To prepare and/or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions
  • In compliance with UK, EU/FDA quality rules and guidelines, to manage the resources, procedures and reports necessary to ensure effective execution of the external supplier audit program to a defined schedule, in conjunction with Global Quality Assurance
  • In conjunction with QA, to perform external audits and internal audits as deemed necessary (e.g. for-cause investigations and unscheduled cGMP audits). Provide support to management during third-party audits
  • To independently verify the audit reports and programme compliance, escalate any adverse trends or major non-conformances reported and make recommendations on appropriate corrective action in support of the approval / rejection of suppliers or products
  • To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements
  • In conjunction with the concerned departmental personnel, develop suitable reporting mechanisms (e.g., key quality indicators) which provide assurance of effective quality oversight of both internal and externally contracted manufacturing and testing activities
  • To keep up to date with current guidelines and regulatory requirements (e.g. Pharmacopoeial changes) in respect of quality requirements
  • Implement and maintain Standard Operating Procedures, as required
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Education/Experience

  • Degree level education or equivalent experience
  • Eligible QP (UK qualified, under the Permanent Provisions)
  • Relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment
  • Good understanding and working knowledge of the Pharmaceutical Industry

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Manufacturing Supervisors (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

As part of the ongoing expansion project in Livingston we are now seeking interest for key roles within the Manufacturing team, including Manufacturing Supervisors.

Job Summary

To co-ordinate the execution of manufacturing steps according to defined procedures and protocols, in line with cGMP work practices and quality standards. This role is dedicated to the supervision of production, production resources and will review, organise and where necessary develop systems / processes in order to achieve:

  • Effective supervisory control production activities within functional area
  • Effective management of a team of manufacturing scientists/operatives
  • Effective planning and co-ordination of activities within functional area
  • Liaise with support functions to ensure appropriate use of resource

Responsibilities

  • On a day to day basis, co-ordinate manufacturing technicians to execute production activities to deliver product on time, right first time and within budget
  • Ensure that all production steps defined by SOPs, production records and protocols are executed in compliance with cGMP standards
  • Ensure that shift handovers are carried out effectively
  • Ensure that direct reports are appropriately trained and competent in procedures
  • Ensure procedures reflect expected manufacturing techniques and current best practice
  • Effective management of people including; holidays, overtime, absence, performance, disciplinary and grievance
  • Development of manufacturing scientists/operatives within team
  • Effective root cause analysis of events and implementation of appropriate corrective actions
  • Ensure the manufacturing areas are audit ready at all times
  • Ensure compliance with health and safety requirements including reporting and investigating incidents
  • Undertake any other duties as requested by line manager in accordance with company requirements

Job Requirements

Experience:

  • Educated to degree level in relevant qualification, or equivalent experience
  • Minimum of 3 years relevant production experience
  • Experience in manufacture of pharmaceutical, vaccine and/or medical devices
  • Experience of managing people is highly desirable
  • Experience in lean manufacturing/six sigma is highly desirable

Required Skills:

  • Strong communication and leadership skills
  • Technical understanding of biotechnology manufacturing processes
  • Leads by example and acts with integrity
  • Ability to work under pressure and effectively manage priorities

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Deputy Head of Process Development (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

To help support growth and development of our Vaccines we are actively looking for a Vaccine or Biologics Health Science focussed Deputy Head our of Process development Team. You will undertake the management of a highly experienced team of development scientists in the delivery of new vaccine products from early development into manufacturing. Technology Transfer, scale up, optimisation, implementation and GXP manufacture using technical and scientific expertise in the Vaccine / Biologics discipline. Further scale up / optimisation for robustness, consistency and yield for commercialisation. Provide site wide technical and investigational support through data evaluation and laboratory work. This is a high profile role with Global Valneva responsibilities and interactions at senior levels of the site and company.

Responsibilities

  • Manage and lead new vaccine product introduction by Technology Transfer. Ensure effective and timely new process establishment with a hands on approach
  • Lead multi-disciplinary project teams to ensure on-time initiation of clinical manufacture for new or upscaled vaccine products
  • Manage the GXP manufacture, closure and reporting of clinical vaccines, including cell banks, viral banks and vaccine batches through to sterile bulk Drug Product formulation
  • Identify and manage delivery of process development / improvement projects, from conception to validation, with a view to increased process robustness, yield and success rate or reduced COGs
  • Management of experienced senior scientists to ensure ownership and delivery of assigned project tasks, systems and areas of responsibility to agreed target dates
  • Provide technical expertise, troubleshooting and lead key technical investigations / assessments, utilising critical trended data to support on time delivery of Quality Investigations
  • Support regulatory submissions by provision or review of technical reports and/or data
  • Ensure development Proposals, Plans and Reports are generated with appropriate risk & commercial considerations, impacts and milestones for delivery, and aligned with business requirements and site projects, goals & objectives
  • To deputise for the Head of Function or other departmental colleagues as required
  • Deliver key critical data for the identification and mitigation of process risks or failure mechanisms through trending and escalation
  • Drive continuous process improvement and provide technical support to key site projects and business deliverables
  • Manage and track on time delivery of department owned Quality Management System actions and documentation
  • Represent the company to external contacts such as customers, suppliers and regulatory authorities for technical discussions
  • Lead by example in the development and maintenance of an enthusiastic, supportive and collaborative environment within the team, across the site and between sites
  • Shift work and out of hours work as required
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Job Requirements

Experience:

  • PhD qualified preferable, or extensive additional relevant experience in Vaccines / Biotech discipline
  • Extensive experience (10+ years) of working within the Vaccine or Biologics Health Science Industrial sector, in Process / Assay Development, Manufacture or Analytical functions, particularly viral products
  • Proven track record in leadership of major, complex, time critical, multi-disciplinary projects involving diverse departmental teams
  • Proven Line Management capabilities of experienced Senior Scientists (5+ years)
  • Excellent understanding of protein chemistry and characterisation and their application to clinical manufacture processes
  • Strong GxP understanding and experience
  • Strong commercial awareness and demonstrable leadership
  • Good experience of statistical data analysis and process trending
  • Good experience of change management and risk analysis

Required Skills:

  • Excellent Scientific understanding of vaccines or protein chemistry through development, manufacture or analytics
  • Ability to confidently communicate at all levels of organisational structure
  • Excellent team management
  • Strong strategic prioritisation capability
  • Analytical thinking
  • Team player with awareness of impact on people, process and systems

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Principal Quality Assurance Specialist (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialise two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen at Valneva Scotland for a Principal QA Specialist within the Quality Assurance Department to support our team in Livingston.

Job Summary

To provide quality technical expertise for the development, optimisation and introduction of quality management processes associated to manufacturing site operations for existing and proposed new products. To define, develop and deliver implementation of improvement quality projects for robustness, consistency, success and enhanced outputs.

Responsibilities

  • Act as main support to quality assurance management team including the Head of Quality Assurance and Head of Quality Operations assuming responsibility for reporting status position, providing updates on departmental activities and risks
  • Deputise for the line manager (Head of Quality Assurance) and team colleagues as required, and ensure owned tasks are assigned deputies in their absence
  • Provide and support the leadership of the quality management team during third-party audits
  • Monitor, improve and maintain quality management procedures to ensure compliance with EU / FDA Good Manufacturing / Distribution Practice as well as other appropriate regulatory authorities for the manufacture and testing of pharmaceuticals
  • Lead, co-ordinate and support all quality management systems in accordance with relevant Standard Operating Procedures, including but not limited to:
    • CAPA
    • Change requests
    • Deviations (including Quality Investigations and OOS)
    • Complaints (customer / supplier)
    • Development Studies / Reports
    • Risk Management
    • QMS data logs
    • Room Release documentation
    • Batch record review (including PPRs, PTRs, MPRs, SPRs)
    • Supplier Assurance processes (including external audits)
    • Validation
  • Progress department QMS activities to agreed timelines
  • Be accountable for on time document management and performance measurement
  • Lead and support the delivery of key quality metrics for the Quality Management Systems ensuring such metrics are available to management to drive continuous improvement and compliance with current regulations, quality requirements and Valneva business needs. Presentation of key Quality Metrics to the Site monthly QRB
  • Lead and assume responsibility for trending and reporting on batch review/release process and quality management system data
  • Utilise critical quality management trended data to support site management of changes. Additionally analyse key critical quality data for the identification and mitigation of process risks or failure mechanisms through trending and escalation
  • Act as main site wide quality expert including being key role in troubleshooting and lead key technical investigations, risk assessment, change management and site projects
  • Provide principal quality assurance support and leadership in the implement of site project activities which will support the commercial manufacturing process
  • Identify and lead the delivery of quality improvement projects, from conception to implementation, with a view to increased quality robustness and oversight to support site commercial manufacturing activities
  • Perform training of staff within the quality assurance department, across the site and between sites in areas of expertise where required
  • Actively contribute to the development, maintenance, support and collaborative of an effective working environment within the quality assurance team, across the site and between sites
  • To deputise where appropriate and undertake any other reasonable duties as requested by the Head of Quality Assurance, in accordance with company requirements
  • Shift work and out of hours work as required

Experience

  • Experience of working within a GMP / GDP manufacturing environment
  • Experience of working within MHRA / EU / FDA accredited facilities
  • Previous experience of working to tight deadlines and re-prioritising workload
  • Proven experience of working with operational excellence improvement tools
  • Experience of leading and delivering quality metrics

Required Skills

  • Strong attention to detail
  • Clear and effective communication skills
  • A logical approach to problem solving
  • Pro-active self-starter with ability to engage and motivate others
  • Proven ability to manage own workload
  • Ability to analyse and interpret quality data
  • Multi-tasker with ability to work to changing priorities
  • Ability to work to own initiative and successfully contribute as part of a team

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QC Lab Manager – Micro (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen for a QC Lab Manager (Micro) to join our team in Livingston based team on a 12 month fixed term contract.

Job Summary

To provide oversight and co-ordinate the routine running of the QC Microbiology. Provide technical expertise and guidance to support Sterility Assurance, Microbiology and Facility Contamination Control (FCC) initiatives on site.

Responsibilities

  • Ensure that EOHS requirements are met by the team, including individual/team training, and that any incidents are investigated and reported in a timely manner to the Head of Quality Control and the EOHS department.
  • To manage Microbiology activities in support of manufacturing schedules and support FCC activities
  • Oversee the execution of microbiology activities according to defined SOPs and protocols with timely reporting of issues to relevant staff
  • Provide support as Subject Matter Expert (SME) in microbiologically related investigations and other problem solving forums
  • Maintain knowledge and competence to undertake tasks within the team, for example, at times of absence or high workload
  • Ensure testing in the microbiology laboratories is scheduled and performed in a timely manner and in alignment with the Manufacturing Master Planning Schedule
  • Manage and maintain facilities, resources and equipment required to adequately support microbiology activities
  • Ensure direct reports are appropriately trained and competent in the procedures they are conducting, and are in compliance with cGMP working practices at all times
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of Quality Control, Head of Facility Contamination Control (FCC) and Qualified Person (QP)
  • Manage and co-ordinate on time delivery of QMS documentation by the team
  • Ensure the principles of Data Integrity are deployed within the team and that issues are escalated to the Head of Quality Control in a timely manner
  • Ensure high standards of housekeeping are maintained within areas of responsibility
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative team within QC
  • Develop, collate and report key quality/business related metrics, and use such metrics to drive a culture of continuous improvement and process efficiencies within areas of responsibility
  • Contribute, encourage and support staff development activities
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Support shift and out of normal hours work, including weekends, as required to support business requirements
  • Deputise for the Head of QC during times of absence or a need for technical expertise

Experience

  • Educated to degree level or equivalent experience
  • Experience within a QC Laboratory working to GMP within a recognised quality system (3+ years)
  • Knowledge of GMP guidelines and regulatory bodies
  • Previous supervisory experience in a lab environment preferred

Required Skills

  • Ability to lead and co-ordinate work within a busy QC laboratory
  • Ability to motivate and engage an effective workforce
  • Ability to develop and manage change projects effectively and efficiently
  • Effective communication and presentation skills (for internal and external interactions)

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Manufacturing Shift Leaders (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

As part of the ongoing project in Livingston we are now seeking interest for key roles within the Manufacturing team and are seeking interest in our Manufacturing Shift Leader positions.

Job Summary

To co-ordinate the execution of manufacturing steps according to defined procedures and protocols in line with cGMP work practices and quality standards. This role is dedicated to the management of production, production resources within a shift and will review, organise and where necessary develop systems / processes in order to achieve:

  • Effective control of all production activities
  • Effective management of a small team of supervisors
  • Effective planning and co-ordination of activities within manufacturing
  • Effective planning and co-ordination with support functions

Responsibilities

  • On a day to day basis coordinating all supervisors and senior technicians to co-ordinate production plans within a shift in order to deliver product to appropriate time, quality and costs
  • To make sure that all production steps defined by SOPs, production records and protocols are being executed in compliance with cGMP standards
  • Ensuring manufacturing rooms are prepared ready for activities, pick lists submitted in time to ensure raw materials available. PPRs and labels available in room prior to activities commencing
  • Ensure that there are clear systems for shift handovers
  • Working in cleanrooms / supervising activities as required
  • Ensuring that all paperwork has been completed for room activities prior to staff leaving room
  • To oversee that best cGMP work practices and techniques to produce product within specification are being applied, ensuring that when in operation equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Ensure that all production supervisors and staff are appropriately trained and competent in the procedures they are conducting and are in compliance with best cGMP working practices at all times
  • Ensure PPRs are kept up to date to reflect expected manufacturing techniques to remove any ambiguity in instructions
  • Responsibility for coordination and planning of cellbank activities
  • Responsibility for coordination and planning FBS qualification activities
  • Responsibility for coordination and planning virus seedbank manufacture
  • Responsibility to motivate supervisors and their staff to help when there are additional pressures
  • Promptly reporting any issues requiring engineering intervention
  • Develop and ensure delivery of a training plan to build on the skills of current production personnel and allow rapid contribution from new personnel
  • Be responsible for the development, collating and reporting of key quality and business metrics and use such metrics to drive a culture of continuous improvement
  • Identifying opportunities for improvements
  • Responsibility for ensuring that any deviations, change controls or CAPAs related to materials, facilities, processes or procedures within your shift are escalated and addressed within agreed timelines. Reviewing and approving QMS items, ensuring that they are completed to a high standard
  • Liaise with all manufacturing staff, ensuring that all direct and indirect production areas are clean, tidy and well organised and in a state of continuous inspection readiness
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Completion of Goals and Objectives, 121s, mid year reviews and end of year reviews for staff, within expected timelines
  • To undertake any other duties as requested by line manager in accordance with company requirements

Job Requirements

Experience:

  • Educated to degree level in relevant qualification, or equivalent experience
  • Minimum of 5 years relevant production experience at senior level
  • Proven track record of supervising a team of 4 or more
  • Experience in vaccine production / commercial
  • Animal cell culture experience
  • Cell bank experience

Required Skills:

  • Flexibility, as there may be a variance in daily schedules from time to time (shift / weekend)
  • Good understanding and working knowledge of the Pharma industry
  • Maintenance of a professional attitude
  • Confidence in dealing with difficult staff
  • Encouraging and developing staff
  • Ability to recognise staff behaviours, rewarding good behaviours and swiftly dealing with any issues
  • Ability to develop a team culture

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Graduate Manufacturing Scientists (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen in Livingston for Graduate Level Manufacturing Scientists, working a 12 hour shift based system

Job Summary

The purpose of this role is to execute defined and trained manufacturing steps for the production of a Covid-19 vaccine according to set procedures and protocols and according to best cGMP work practices and Quality standards.

Key Responsibilities

  • Execute production steps defined by SOPs, production records and protocol for manufacture of a Covid vaccine
  • Apply best cGMP work practices and techniques
  • Conduct on-time reporting according to defined document management standards
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the supervising team
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Support change controls, investigations and CAPAs in the most diligent manner
  • Identify areas for continuous improvement and escalate those to the respective manufacturing supervisor or appropriate person
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Shift work and out of hours work as may be required
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Be accountable that the individual workspace is clean, tidy and well organised

Experience

  • Relevant degree or HNC/HND or equivalent experience
  • Experience of cell culture and aseptic technique is desirable
  • Cleanroom experience
  • Experience of working within a cGMP environment
  • Experience of following SOPs within defined cGMP work practices

Competencies

  • Self-motivated individual
  • Excellent comportment in cleanroom environment
  • Good attention to detail and adherence to procedures
  • Ability to execute activities following direction
  • Experience of working in a busy team and at times, demanding environment

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Manufacturing Process Technicians (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen in Livingston for Manufacturing Process Technicians.

We are currently operating a variety of shift patterns (both 8 hour and 12 hour patterns) , all will include some form of weekend working.

Job Summary

The purpose of this role is to execute defined and trained manufacturing steps for the large-scale production of a Covid-19 vaccine candidate, according to set procedures and protocols whilst adhering to best cGMP work practices and Quality standards.

Key Responsibilities:

    • Execute production steps defined by SOPs, production records and protocols for manufacture of our Covid-19 vaccine candidate
    • Setting up, operating and monitoring complex manufacturing equipment
    • Apply best cGMP work practices and techniques
    • Conduct on-time reporting according to defined document management standards
    • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the supervising team
    • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
    • Ensure that at any time, equipment, facilities and materials used in the area of responsibility comply with defined standards
    • Support change controls & investigations in the most diligent manner
    • Identify areas for continuous improvement and escalate those to the respective manufacturing supervisor or appropriate line manager
    • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
    • Choose & commit to work one of the various shift patterns on offer
    • To undertake any other duties as requested by the line manager in accordance with company requirements
    • Be accountable that the individual workspace is clean, tidy and well organised

Experience:

  • Relevant degree, HNC/HND or equivalent experience
  • Experience as a key operator on setting up and operating complex manufacturing equipment
  • Cleanroom experience
  • Experience of working within a cGMP environment
  • Experience of following SOPs within defined cGMP work practices

Competencies:

    • Self-motivated individual
    • Good attention to detail and complete adherence to procedures
    • Ability to execute activities following direction
    • Excellent behaviour and demeanour in a cleanroom environment
    • Experience of working in a busy team and demanding environment

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Manufacturing Scientists (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen in Livingston for Manufacturing Scientists.

We are currently looking for cover on our rotational 12 hour shift pattern, which includes night shift and weekend working.

Job Summary

The purpose of this role is to execute defined and trained manufacturing steps for the production of a COVID-19 vaccine according to set procedures and protocols and according to best cGMP work practices and Quality standards.

Key Responsibilities

  • Execute production steps defined by SOPs, production records and protocol for manufacture of a Covid vaccine
  • Apply best cGMP work practices and techniques
  • Conduct on-time reporting according to defined document management standards
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the supervising team
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Support change controls, investigations and CAPAs in the most diligent manner
  • Identify areas for continuous improvement and escalate those to the respective manufacturing supervisor or appropriate person
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Shift work and out of hours work as may be required
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Be accountable that the individual workspace is clean, tidy and well organised

Experience

  • Relevant degree or HNC/HND or equivalent experience
  • Experience of cell culture and aseptic technique is desirable
  • Cleanroom experience
  • Experience of working within a cGMP environment
  • Experience of following SOPs within defined cGMP work practices

Competencies

  • Self-motivated individual
  • Excellent comportment in cleanroom environment
  • Good attention to detail and adherence to procedures
  • Ability to execute activities following direction
  • Experience of working in a busy team and at times, demanding environment

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QA Specialists (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

As we continue to expand our business in Livingston, we are looking for a number of experienced QA Specialists.

Your responsibilities will include:

  • Developing, monitoring, improving and maintaining procedures to ensure compliance with EU/FDA Good Manufacturing Practice (GMP) for the manufacture and testing of pharmaceuticals.
  • Performing activities and reviews in accordance with relevant Standard Operating Procedures (SOP), including but not limited to:
    • Risk assessments
    • CAPA
    • Change requests
    • Deviations
    • Complaints (customer / supplier)
    • Development Studies / Reports
    • Batch record review
    • Product defect reporting and Quality Investigations
    • Technical and Quality Agreements
    • Validation
  • Participating in cross-functional projects
  • Developing, implementing and monitoring Continuous Improvement activities
  • Providing QA coaching / guidance for cross-functional groups to ensure compliance with KPI targets including functional QA if required
  • Co-ordinating and providing training across functional groups in Quality Procedures, GMP requirements and QA concepts
  • Providing support to management during third-party audits
  • Performing internal housekeeping, in-process visits and quality audits
  • Performing external quality audits, supporting Livingston and other Valneva sites
  • Implementing and maintaining Quality Standard Operating Procedures, as required
  • Training staff in QA related procedures and concepts as directed by line manager
  • Undertaking any other duties as requested by the line manager in accordance with company requirements

What experience will you need?

  • Educated to degree level in relevant qualification or relevant experience
  • Proven and logical approach to problem solving
  • Experience of working effectively in a team, influencing as appropriate
  • Experience of working within a GMP manufacturing environment
  • Knowledge / experience of the requirements for distribution of pharmaceutical products

Your key skills will include:

  • Attention to detail
  • Excellent organisational skills
  • Effective communication skills
  • Flexible and adaptable team player

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Training Manager (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

Do you have a background in Training and enjoy getting the best out of people? If so, we’d love to hear from you! An opportunity has arisen at Valneva Scotland for a Training Manager within the HR Team.

Job Summary

Experienced Training Manager to support our organisational training strategy, oversee the implementation of new systems of work and manage the outcomes. Liaising with all our departments, you will gain an understanding of individuals’ development and training needs and produce innovative ideas and initiatives that move us forward in our learning culture, recording compliance and adherence to GDPR. Driving forward a blended training initiative, fostering our strong team culture, ensuring our people are knowledgeable and future-ready.

Key Responsibilities

  • Overseeing all training programmes that will include web based seminars, group sessions, training videos and more
  • Determine training needs and requirements for the organisation by partnering with managers / departmental training coordinators and the wider business
  • Help departments adopt competency based training / scheduled of all training activities
  • Create training calendars to improve training efficiency
  • Support departmental training coordinators to ensure current training materials are relevant and appropriate
  • Support departmental training coordinators to modify and create training materials to meet specific departmental training needs
  • Support departmental training coordinators to develop and ensure delivery of a training plan to build on the skills of current personnel and allow rapid contribution from new personnel
  • Work with managers / departmental training coordinators to ensure there are systems in place to highlight skills gaps and develop training plans to combat this
  • Manage training costs to ensure training represents good value for money and costs are maintained within budget
  • Keeping abreast of new educational and training techniques as well as ground breaking methodologies
  • On a day to day basis plan, co-ordinate training activities across all departments
  • To oversee that best cGMP work practices and techniques to train staff are being applied.
  • Ensure that all staff are appropriately trained and competent in the procedures they are conducting and are in compliance with best cGMP working practices at all times
  • Maintain the training facilities in an operationally ready state ensuring any issues requiring engineering intervention are reported promptly
  • Develop and ensure delivery of a training plan to build on the skills of current personnel and allow rapid contribution from new personnel
  • Help develop and maintain competency levels within all manufacturing
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Actively contribute to the development and maintenance of an enthusiastic, supportive, and collaborative environment within the team setting.
  • Ensure that all staff are appropriately trained and competent in the procedures they are conducting and are in compliance with best cGMP working practices at all times working with department head / supervisors.
  • Help develop and maintain competency levels within all JEV manufacturing
  • To undertake any other duties as requested by line manager in accordance with company requirements
  • Responsible for all training record to be accurate & compliant via QMS & any local system.

Required Skills

  • Good understanding and working knowledge of the Pharma industry
  • Maintenance of a professional attitude
  • Encouraging and developing staff
  • Ability to develop a team culture

Expertise

  • Experience in coordinating activities across multiple departments
  • Experience with traditional and modern training methods (classroom training, e learning, workshops, mentoring etc.)
  • Proven track record of training staff

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Senior Technical Assistant QC Analytics Austria (f/m/d)

  • Position: Full time
  • Location: Vienna, Austria

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Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung, Revision und Verifizierung analytischer Daten
  • Erstellung, Revision und Überprüfung der GMP-relevanten Dokumenten (zB Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Zumindest 4 Jahre Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein Mindestgehalt von EUR 40.000,- brutto pro Jahr (Vollzeitbasis) gilt.

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Logistic Planning Coordinator (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

We have an immediate opening within our supply chain team as a Planning Co-ordinator.

As a primary liaison between Valneva, and our 3PL suppliers ensuring the timely availability and delivery of materials and finished goods, ensuring visibility of shipping activities and long term shipment forecasting. Responsible for managing data for European and international shipments and provide support for the transportation process with stakeholders. Working with internal departments, international company sites, transportation companies and clients. Responsible for shipping and record keeping for international transactions. Ensures all documentation adheres to import-export policies and laws.

Responsibilities

  • Co-ordinate with key internal and external stakeholders to prepare and progress material and shipment planning
  • Work closely with internal stakeholders, QA, & QP for release of finished Goods for shipment
  • Ensure imports/exports are correctly logged with Customs through 3PL
  • Preparation of customs and excise documentation as required
  • Assist with coordinating the delivery and shipment of orders to destinations globally
  • Manage any delivery issues that arise and help ensure all queries are fully resolved; dealing with related queries promptly
  • Liaise with 3PLs to obtain up to date shipment information
  • Execute logistics plan to move products and packages to reach destinations on schedule
  • Support the import and export of goods through 3PL
  • Ensure effective business relationships are maintained
  • Maintain delivery plans to manage customer delivery expectations
  • Ensure that deviations to compliance (Quality and HSE) or business metrics are escalated within the team and managed through change controls, investigations and CAPA’s in an appropriate, timely fashion and in alignment with Quality Operations
  • Support planning functions when required
  • Contribute to an environment of energy, enthusiasm and motivation
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience

  • Relevant work experience in a regulated industry (FDA, EMEA etc)
  • knowledge of quality management systems and GDP
  • knowledge of creating and writing SOP and related documents, but not essential
  • Ability to focus and prioritise critical tasks and general workload
  • Understand the role of the freight forwarder
  • Knowledge of importing and exporting goods
  • Ideally a relevant qualification, although a sound experience within import/export role is more important

Required Skills

  • Ability to cope under pressure and work towards time sensitive deadlines
  • Decision maker essential
  • An excellent approach to resolving issues
    • Self-motivated, energetic and value-driven
    • Ability to work well on own initiative, under pressure as well as an excellent team player
    • be able to think ‘outside the box’
  • Excellent time management and organisation skills
  • Effective communication skills
  • Familiarity working within a GxP environment and with quality management systems
  • Understanding of transportation limitations, regulations and issues

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Regulatory Affairs Specialist (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen within the Regulatory Affairs team for the position of Regulatory Affairs Specialist.

The main purpose of this role will be to support the Regulatory Affairs team with the preparation, compilation and interpretation of information necessary for regulatory submissions associated with CMC (Chemistry, Manufacturing and Controls) Modules for successful granting, maintenance of and variation to such licenses to meet business objectives and regulatory requirements.

Additional responsibilities associated with the role include:

  • Progress and track on time delivery of department owned Quality Management System actions and documentation.
  • Perform the regulatory review of cross-functional owned documents (i.e QMS, Assay/Process Plans/Protocols and Reports).
  • Provide general regulatory advice on quality related issues and determine whether change requests are compliant with the terms of all applicable license documentation within field of responsibility
  • Advise on compliance / regulatory requirements for process and assay development and technology transfer activities to ensure that regulatory requirements are incorporated into the planning of development work (i.e. validated, set-up and compliant with regulatory guidelines)
  • Provide regulatory support in the implementation of site project activities
  • As required, to support with the preparation for meetings with regulatory authorities and site GMP inspections and to participate in site GMP inspection

Experience

Degree level educated (or equivalent experience), the successful candidate should ideally have knowledge/experience of the manufacture of a biological product in a commercial environment, with an understanding of GMP processes. Regulatory experience in CMC submissions (dossier preparation and maintenance) is desirable but not essential. Candidates, who have relevant experience in the biopharmaceutical industry and want to develop their current skillset, will be considered.

Required Skills

To be successful in the role you should have good scientific writing, IT and oral communication skills with a strong attention to detail and be a self-motivated and conscientious team player with good organisational skills. The ability to multi-task and work under pressure with changing priorities is essential.

This is a unique and exciting opportunity for someone looking to develop their career in the field of Regulatory Affairs.

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Senior QC Technician (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

We have an immediate opening within our QC team as a Senior QC Technician.

To supervise and execute defined and trained Quality Control department tests for the release of raw materials, All vaccine intermediate products and the final products according to defined procedures and protocols and according with best cGMP work practices, Quality standards and metrics.

  • Execute analytical procedures, for testing of raw materials, intermediate products and final products, according to defined SOPs and protocols and ensure that the QC team is in compliance with same
  • Apply best cGMP work-practices and techniques to test and release raw materials and product within specification
  • Ensure that all QC analysts are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times
  • Ensure subcontract of QC testing and dispatching to approved suppliers is performed according to defined procedures and in compliance with GMP
  • Be responsible for the development, collating and reporting of key quality and business metrics, and use such metrics to drive a culture of continuous process improvement within the area of responsibility
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the QC Analysts
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of QC
  • Be accountable for the analytical laboratories being clean, tidy and well organised and in a state of continuous inspection readiness
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Issue, manage and close-out change controls, investigations and CAPAs in a timely fashion
  • Identify areas for continuous improvement and escalate those to the QC Manager
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience

  • Working within a QC laboratory environment, working to GMP within a recognised quality system
  • Ability to prioritise, organise and schedule work within a busy laboratory
  • Experience of writing and working to SOP documentation
  • QMS experience
  • Experience in biological assays
  • Validation and qualification of assays knowledge would be advantageous
  • Experience in reference standard management
  • Environmental monitoring and associated microbiology knowledge / experience
  • Experience driving a team to achieve individual, team and organisational objectives
  • Experienced in relationship handling with external bodies, such as suppliers, regulatory and audit authorities

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Technical Assistant QC Analytics Austria (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria

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Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung analytischer Daten
  • Erstellung, Revision und Überprüfung von GMP-relevanten Dokumenten (zB Standardarbeitsvorschriften, Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Mehrjährige Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment ist von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen ist von Vorteil
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen ist von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits wie Gleitzeit, Sodexo-Essensgutscheine, leistungsorientierter Bonus, etc.

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein KV-Mindestgehalt von EUR 34.000,- brutto pro Jahr (Vollzeitbasis) gilt.

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Technical Assistant QC Analytics (f/m/d)

  • Position: Full time
  • Location: Vienna, Austria

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IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung analytischer Daten
  • Erstellung, Revision und Überprüfung von GMP-relevanten Dokumenten (zB Standardarbeitsvorschriften, Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Mehrjährige Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment ist von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen ist von Vorteil
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen ist von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits wie Gleitzeit, Sodexo-Essensgutscheine, leistungsorientierter Bonus, etc.

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein KV-Mindestgehalt von EUR 34.000,- brutto pro Jahr (Vollzeitbasis) gilt.

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SOX – Internal Controls Specialist (Livingston, UK)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

As part of our ongoing recruitment and growth plans we now have a new position for an experienced audit/ internal audit professional with experience of supporting to SOX standards.

Role summary: The ideal Internal Controls Specialist – SOX is an effective team collaborator who is responsible for assisting in the execution of the annual Sarbanes-Oxley Section 404 compliance efforts

Responsibilities

  • Assist in planning of SOX program in terms of scope, and work program of individual processes or systems
  • Evaluate risk and likely sources of potential financial misstatement for key operational processes
  • Apply and assess financial reporting impact based on knowledge of Accounting Principles (e.g., IFRS, GAAP)
  • Partner with company financial, operational and information technology groups to conduct walkthroughs, assess control design, and test control operating effectiveness for processes across the organization, with a focus on new transactions, significant changes, or other areas of high risk
  • Execute SOX Program Management responsibilities including the coordination, execution and monitoring of controls testing, exceptions and remediation
  • Document test results in form of workpapers and give support for an informed, objective opinion of the risk exposure
  • Conduct follow-up on both open and past due SOX observations on a regular basis
  • Act as a liaison to the company’s external auditors on their annual audit and the company’s SOX program
  • Drive control optimization and automation opportunities, data analytics and process improvements
  • Assist in the periodic update and distribution of corporate governance documents (including quarterly 302 questionnaires and control self-assessments)

Education/ Experience

  • 3-5 years of SOX, financial audit, internal audit, or related internal controls required.
  • Bachelor’s Degree in accounting, business or related discipline(s) required.
  • Strong understanding of IFRS, US GAAP and Sarbanes-Oxley required.
  • Prior experience with ERP (Microsoft Dynamics AX) and an internal controls management
  • software (Auditboard) preferable.
  • Job relevant certification a plus (e.g., CPA, CIA)

Required skills

  • Strong communication skills presenting internal control and risk matters in an understandable
  • way across various forums and levels of the organization with the right level of detail
  • Strong oral and written communication skills, including sound presentational skills
  • Excellent organizational and interpersonal skills and ability to work as part of a
  • virtual/international team
  • Adaptable to working in a fast paced, ever-changing environment
  • Striving for continuous improvement and optimization
  • Ability to work well independently as well as the ability to work well with stakeholders and
  • communicate the benefits of tax initiatives.
  • Flexibility in resolving issues and addressing changing priorities
  • The ideal candidate is a critical thinker internal control environment. They are organized with
  • excellent analytical and problem-solving skills

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Senior HR Generalist (Solna, Sweden)

  • Position: Full time
  • Location: Solna, Sweden

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Är du en erfaren och drivet HR-proffs som brinner lite extra för Talent Management, coachning och nätverksbyggande? I så fall bör du läsa vidare och söka tjänsten som Senior HR Generalist till Valneva!

Om Valneva

Valneva är ett vaccinföretag som specialiserat sig på utveckling och kommersialisering av profylaktiska vacciner mot infektionssjukdomar där betydande ouppfyllda medicinska behov finns. Vår vision är att bidra till en värld där ingen dör eller lider av en sjukdom som kan förebyggas av vaccination. Valneva har flera vaccinkandidater under utveckling, bland annat vaccinkandidater mot Borrelia, COVID-19 och chikungunya. Valnevas portfölj innehåller i dagsläget två kommersiella resevacciner: ett för förebyggande av japansk encefalit och ett för förebyggande av kolera. Valneva har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med runt 700 anställda.

Valneva Sweden AB är ett bolag där hela värdekedjan finns på plats i Solna; från inköp av råmaterial till export och försäljning, tillverkning av bulkvaccin, aseptisk fyllning, syning och packning, samt tillhörande supportfunktioner. Bolaget samarbetar på en daglig basis med kolleger på andra Valneva-bolag runt om i världen.

Mer information hittar du på www.valneva.com.

HR teamet

Gruppen består, utöver HR-chef, av två Seniora HR Generalister som arbetar brett inom HR-området. I teamet arbetar vi tillsammans och stöttar varandra i våra ansvarsområden. Hela teamet arbetar nära cheferna i organisationen.

Om rollen

I rollen som Senior HR Generalist kommer du arbeta i en bred HR-roll med huvudansvaret för frågor kopplade till Talent Management. Rollen förutsätter nätverksbyggande såväl internt som externt, och du ges chansen att både få arbeta med och påverka hela processen. Du kommer in i en organisation som verkligen sätter ett värde på affärsdriven och hållbar HR.

I rollen som Senior HR Generalist kommer du

  • Arbeta såväl strategiskt som operativt med bolagets lärande och utveckling
  • Hålla i utbildningar och utbilda organisationen
  • Coacha, inspirera och motivera
  • Utveckla onboarding-processen
  • Rekrytera och utveckla samarbeten med externa leverantörer

Rätt kandidat har flera års relevant erfarenhet av kvalificerat och brett HR-arbete. Du förstår vikten av en stark företagskultur och sätter dig snabbt in i affären. Rollen kräver ett coachande förhållningsätt och en förmåga att självständigt driva projekt framåt. Du ser potentialen i varje medarbetare och förstår vikten av en lärande organisation och ett starkt ledarskap.

Dessutom har du erfarenhet av

  • Kompetensutvecklande insatser
  • Bemanningsplaner och successionsplanering
  • Arbete med fackliga relationer och förhandling
  • Digitalt förhållningsätt
  • Arbete med förbättringar och effektiviseringar i både HR och verksamhetens sätt att arbeta.

Som person trivs du att arbeta såväl självständigt som i team. Du är en god kommunikatör och trivs i en miljö med många kontaktytor. Du har en god förmåga att uttrycka dig i tal och skrift på både svenska och engelska. Du är förändringsbenägen och trivs i en snabbfotad miljö. Du har en akademisk utbildning inom PA eller likvärdigt. Vi ser fram emot din ansökan!

I denna rekrytering samarbetar Valneva med Peopleprovide. Vid frågor om tjänsten kontakta Ondina Moretti eller Anders Holtenius på PeopleProvide. Ondina.moretti@peopleprovide.se, anders@peopleprovide.se

Sista ansökningsdag: 1/5

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Produktionsingenjör (Solna, Sweden)

  • Position: Full time
  • Location: Solna, Sweden

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Arbetsbeskrivning

Vill du vara med och arbeta för en friskare värld? Valnevas vision är att bidra till en värld där ingen dör eller lider av en sjukdom som kan förebyggas av vaccination.

Vi söker nu en produktionsingenjör till den nya moderna fabriken i Tomteboda, Solna.

Valneva är ett globalt företag som utvecklar och tillverkar vaccin där betydande ouppfyllda medicinska behov finns. På Valnevas site i Solna tillverkar man det väletablerade vaccinet Dukoral. Sedan 2021 pågår även ett projekt för att tillverka Valnevas egenutvecklade vaccin mot Covid-19, VLA2001 på siten. Ansökan till Europeiska myndigheter pågår.

Kvalifikationer.

Vi tror att du har:
  • Högskoleutbildning i naturvetenskap, maskinteknik eller motsvarande kunskap.
  • Tidigare erfarenhet av att arbeta inom processindustrin.
  • Teoretisk förståelse och skicklig i praktiskt arbete, både mekaniskt och SCADA/HMI
  • Goda kunskaper i tal och skrift på både svenska och engelska.
  • Kompetens inom automationsteknik ses som meriterande.
Som person behöver du en ha god social och kommunikativ förmåga och trivas i en roll där samarbete med olika funktioner inom företaget är A och O. Du är självgående och van att arbeta ur ett helhetsperspektiv med förmåga att själv planera, prioritera och utföra dina arbetsuppgifter på ett lösningsorienterat sätt. Viktiga egenskaper för att lyckas i den här rollen är att du är nyfiken, engagerad och har en vilja att lära och utvecklas.

Ansvarsområde

Rollen som produktionsingenjör är bred och det blir ditt ansvarsområde att leda och utföra förbättringsaktiviteter för att uppnå en effektiv och välfungerande tillverkning av läkemedel på den nya automatiserade fabriken i Solna.

Dina arbetsuppgifter innefattar bland annat att:

  • driva arbetet med att identifiera och implementera förbättringar för att uppnå en effektiv och hög utbytesproduktion.
  • driva optimering och minskning av kostnader i linje med produktivitetsmål och identifiera möjligheter att kontinuerligt förbättra prestandan vid tillverkningen av läkemedelsprodukter.
  • definiera och mäta relevanta nyckeltal.
  • leda tvärfunktionella team.
  • säkra underhåll enligt underhållsplan.
  • utveckla underhållsbehov för läkemedelsproduktutrustning i samarbete med interna och externa funktioner.
  • fungera som kontaktperson mot utrustningsleverantörer.
  • arbeta med ständiga förbättringar enligt Lean
Söker du en roll som erbjuder omväxlande arbetsuppgifter med ständigt nya utmaningar på ett familjärt företag så har du kommit helt rätt!

Ansökan

I rekryteringen av dessa tjänster samarbetar Valneva med Randstad Engineering.
För ytterligare information om tjänsten, vänligen kontakta Rekryteringskonsult Hannah Sandström, 0733-434 534 hannah.sandstrom@randstad.seSista ansökningsdag: 2022-05-09 .
Ansökningar via mail undanbedes då vi inte har möjlighet att hantera dessa pga. GDPR. Urval sker löpande så välkommen med din ansökan redan idag!

Fackliga kontakter
Akademikerföreningen: Birgitta Sundén, 073-715 84 18
Unionen: Niclas Sandberg. 072-316 45 99
E-post: förnamn.efternamn@valneva.com

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Logistics Specialist (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Executing the receipt, handling and storage of materials, equipment, IMPs and other material required for
    Valneva Austria according to current regulations and procedures
  • Maintenance of stock levels
  • Organizing, monitoring and reporting transport activities for materials and equipment at Valneva Vienna Site
  • Monitoring transport temperature data and reporting incidents
  • Performing regular stock checks, equipment qualifications and calibration activities
  • Working actively on harmonization and proposing changes to increase efficiency of processes or utilization of space

YOUR QUALIFICATIONS

  • Graduation from a commercial/technical school (HAK, HTL)
  • At least 5 years relevant cross functional work experience in a regulated industry, preferably within the logistics/warehouse area
  • Highly organized with strong systematic approach to prioritization
  • Excellent interpersonal skills and ability to work flexibly in a small and focused team
  • Capability to work in a fast-changing environment
  • MS Office skills and experience with an ERP-System (preferably MS-Dynamics AX)
  • Excellent interpersonal skills and ability to work flexibly in a small and focused team
  • Knowledge on customs procedures
  • Very good proficiency in English and German

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 30.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

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Business Development Licensing Director (Lyon, France)

  • Position: Full time
  • Location: Lyon, France

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

Key Responsibilities

We are looking for a Business Development Licensing Director to support the activity of the Business & Corporate Development team and takes the lead of R&D partnering activities such as: in- or out-licencing of vaccine candidates and technologies, set up of R&D collaborations or co-developments. The incumbent supports R&D scouting and alliance management activities.

Licensing:

Product or technology in-licensing:

  • Lead the in-licensing process for vaccine candidates or technologies in collaboration with relevant internal stakeholders
  • Support scouting activities to identify relevant candidates or technologies, including pipeline reviews, competitive intelligence and prioritization exercises
  • Lead the due diligence process: set up the due diligence team and coordinate the process, collect due diligence feedbacks, consolidate analysis and provide recommendation to senior management
  • Develop financial model/valuations (discounted cash flows) in collaboration with Finance, define relevant financial deal structure with appropriate benchmarks
  • Build robust business cases and present to relevant committees
  • Lead contract negotiations in partnership with relevant internal stakeholders
  • Coordinate interactions with external partners
  • Ensure regular reporting to relevant committees

Product out-licensing:

  • Lead the out-licensing process for vaccine candidates in collaboration with relevant internal stakeholders
  • Prepare the relevant documents and coordinate the preparation of the dataroom
  • Develop financial model/valuations (discounted cash flows), define relevant financial deal structure with appropriate benchmarks
  • Identify potential partners and prioritize
  • Contact partners and coordinate interactions between Valneva team members and partner
  • Lead contract negotiations in partnership with relevant internal stakeholders
  • Ensure regular reporting to relevant committees

Technology out-licensing:

  • Responsible for technologies (cell line, adjuvant…) out-licensing activities
  • Responsible to generate related revenues according to the agreed budget
  • Lead prospection activities and responsible to have a balanced portfolio of lead opportunities
  • Manage tracking and reporting of existing portfolio of licenses and future partners
  • Deliver technology presentation to prospective partners
  • Develops financial models supporting deal terms/term sheets and negotiation strategies for licensing transactions.
  • Negotiation license agreements with relevant internal stakeholders
  • Ensure consistency with existing license agreements and propose consistent financial valuations
  • Ensure transition with alliance management activities to optimize opportunities
  • Ensure regular reporting to relevant committees

R&D Partnering

  • Support efforts to identify new technologies, products or companies and ultimately new investment ideas that are aligned with the company strategy
  • Negotiate R&D collaborations and partnerships aiming at mutual value creation, anticipate potential issues and challenges and support the R&D team in navigating complex environments
  • Support alliance and contract management: ensure the timely implementation of contractual obligations; maintain a detailed understanding of the executed agreement in order to advise team members of contract requirements, lead or contribute to re-negotiations of existing agreements.

Profile

Education / Experience:

  • Post graduate degree in Biological Sciences + MBA or business/finance degree
  • At least 12 years in pharmaceutical/vaccine industry, including 8-10 years business development, corporate development or licensing with a proven track record of deal sourcing, deal structuring and deal making, specifically licensing transactions.
  • Vaccine experience strongly preferred, previous big pharma ideal.
  • Strong deal sheet demonstrating success across broad variety of R&D deal structures/types.

Required Skills:

  • Thorough knowledge and demonstrated expertise in the pharmaceutical/vaccine industry.
  • Demonstrated understanding of the vaccine development process, operations and key organizational interfaces with a broad range of functions including commercial, R&D, clinical development, IP, finance, legal…
  • Strong analytical skills
  • Observed strength and expertise in working within matrix teams, including cross-cultural teams and of influencing without authority to achieve desired outcomes. Open and communicative personality with an ability to work in interdisciplinary teams.
  • Demonstrated ability to build effective working relationships and successfully influence at all levels across organizations to achieve business goals
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Entrepreneurial spirit, self-starter, proactive, result-driven and goal-getter attitude
  • Excellent oral and written communication skills in English
  • Ability to deliver high-quality work under time pressure
  • Excellent organizational skills, with an ability to prioritize and to manage complex issues and coordinate multiple projects simultaneously
  • Help in the advancement of the Business & Corporate Development team, the development of new skills, and the continuous improvement of quality

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Global Medical Expert (Lyon, France)

  • Position: Full time
  • Location: Lyon, France

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Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

Key Responsibilities

We are looking for a Global Medical Expert to support the activity of the Medical Affairs and contributes to the development of medical strategy and provides Medical input into Brand Strategies and Medical guidance and governance ensuring a successful product launch and support of further life cycle management activities. This role will act as project leader of medical affairs for the launch and works to execute the medical component of the Launch Plan. The Key objectives are to drive Medical Plan and its execution, which ensures that high quality scientific content and medical education efforts are executed to enhance knowledge, medical practice and equitable access to vaccination.

This role interacts internally with the VP Medical Affairs, Medical Science Liaisons (MSLs) and members of the various Brand Teams and externally with Key Opinion Leaders and external other industry stakeholders (medical societies, international scientific organizations…).

  • Develop the Medical component of the Brand Strategy, and develop a Leads the Medical Plan for the assigned products, in support of the Brand Plans: Develop and implement therapeutic area specific medical plans and publication plans. Develop the KOL and Stakeholder engagement plans for successful launch preparations.
  • Take on the project lead for medical affairs in the Chickungunya program and drive all medical affairs related pre-launch activities
  • Responsible to secure effectiveness, quality and compliance by enhancing medical affairs scientific engagement and fully compliant intersection between sciences and commercialisation.
  • Implement and coordinate medical science liaisons teams, including CRM, insights and virtual tools.
  • External Partnership: different external partnership projects (e.g. encephalitis society)
  • Drive the development, attend and present at appropriate meetings (advisory board meetings, investigator meetings, KOL meetings, CME, Valneva meetings, etc.)
  • Provide cross-functional therapeutic and product expertise to the Development program Director.
  • Support the marketing and market access strategy for all Valneva focus products by being a key member on cross-functional teams.
  • Develop and maintain up-to-date knowledge of the therapy areas by reviewing the literature, discussions with key Opinion Leaders and key stakeholders, participating in cross functional interactions, attending scientific congresses, etc.
  • Maintain up to date clinical knowledge in appropriate therapeutic areas, and provide appropriate overall strategic and operational input into Valneva objectives.
  • Take ownership of compliance for the review of materials for external sharing (i.e. MSOP-0045) and Regulatory documents for medical accuracy and compliance with applicable guidelines and regulations.
  • Ensure all Medical activities are compliant with appropriate Valneva code of conduct policy (i.e. DOR on HCP interactions, transfer of value and transparency reporting).
  • Support the development / revision and implementation of Standard Operating Procedures as required.

Execute other duties as may be required by the Vice President Medical Affairs as training and experience allow.

Profile

Education / Experience:

  • MD, PhD or PharmD and experience in relevant therapeutic areas
  • 5+ years of experience in driving and managing the medical strategy for various brands in the pharmaceutical industry
  • Clinical research and trial management experience, and be able to interact authoritatively with key stakeholders and investigators.

Required Skills:

  • Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events.
  • Independent, self-driven, pro-active, extrovert and dynamic
  • Ability to form relationships quickly and have demonstrable persuasive abilities
  • Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as well as in presentations
  • Exceptional leadership capabilities; ability to motivate, inspire Highly organized with attention to detail
  • Strong team player and know how to collaborate and engage many stakeholders across a large organization
  • Solid negotiation and decision making skills
  • Good analytical and numerical abilities
  • Adaptability
  • Innovative and pro-active
  • Strategic thinking
  • Results-oriented attitude
  • Resource management and financial skills to control budgets
  • Be willing to travel.

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Manufacturing Assistant (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Job Summary

We are looking for people to appropriately carry out all cleaning activities related to production support for our various Vaccine Manufacturing Programme, according to set procedures and protocols and to best cGMP work practices and quality standards.

You will be responsible for:

  • Carry out routine cleaning of the commercial manufacturing facility (and CTM facility as required) to a defined schedule to support manufacturing activities
  • Ensure housekeeping within the cleanroom suites and common areas is maintained to a high standard at all times
  • Ensure that response cleans are completed in a timely manner and to appropriate standards
  • Processing of orders picked from stores into the cleanroom to ensure manufacturing schedule adherence and contamination control
  • Support of Manufacturing activities by processing return of cleanroom garments, mops and other items as required
  • Apply best cGMP work practices and techniques
  • Immediately escalate and report any deviations involving materials, facilities, processes or procedures to line management
  • Conduct all activities in a careful and safe manner and in full compliance with HSE requirements
  • Support QMS investigations and any corrective actions and improvement opportunities
  • Identify areas for continuous improvement and escalate those to the line manager
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting
  • Participate in training of staff in areas of expertise
  • Shift work and out of hours work as required
  • To undertake any other duties as requested by the line manager in accordance with company requirements

You will have:

  • A meticulous approach to all cleaning and production support activities
  • Flexibility, as there may be a variance in daily schedules from time to time
  • Previous experience of cleaning in a clean room environment (although on-going training will be provided)

Additional Required Skills:

  • Excellent attention to detail
  • Ability to follow SOPs

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QC Coordinator (Raw Materials) (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Summary

To execute defined and trained Quality Control department tests for the release of raw materials, intermediate products and final products according to defined procedures and protocols and according to best cGMP work practices, Quality Standards and metrics, as well as assisting in the implementation and maintenance of policies for Quality Control department within Valneva. Carry out laboratory tasks as identified by QC department.

Responsibilities

  • Inspection and labelling of Incoming Goods
  • Maintain raw material specifications to ensure continued compliance with current pharmacopoeias (e.g. Ph.Eur., USP)
  • Support / co-ordinate the testing and release of raw materials, ensuring uninterrupted supply of materials to Manufacturing and QC for the manufacturing process
  • Apply best GMP work-practices and techniques to sampling
  • Support co-ordination of the storage of QC reference samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
  • Support co-ordination of sample logistics for all testing, applying best cGMP work-practices and techniques to sampling and management for the release of raw materials ensuring continuous availability of materials into manufacturing and QC to meet production forecast
  • Progress QMS to ensure on time delivery and compliance within the QC department
  • Prepare and submit Purchase Orders for raw material external testing
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
  • Maintain all QC systems, databases, logs and support the generation of QC trend data
  • Be accountable for the QC areas being clean, tidy and well-organised and in a state of continuous inspection readiness
  • Perform routine housekeeping activities in QC including cleaning of equipment and laboratory areas
  • Ensure that all required training is complete in procedures performed and operate in compliance with best cGMP working practices at all times
  • Support QC activities in line with manufacturing schedule, as per rota (including provision of overtime cover as required)
  • Shift work and out of hours work as required
  • Identify continuous improvement opportunities and liaise with QC line management (or other functions) to agree benefits and deployment plans
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Actively contribute to the development of the QC Logistics team, for example, through team meetings
  • Act as departmental point of contact on relevant site projects
  • Support other QC activities in line with the manufacturing schedule

Experience

  • Degree / HND / HNC in chemical/biological sciences or relevant experience
  • Knowledge of usage of Pharmacopoeias is beneficial but not essential
  • Knowledge of GMP guidelines and regulatory bodies
  • Experience in method validation / verification is beneficial but not essential
  • Experience of Quality Management Systems
  • Experience in working with Microsoft Excel, and ERP systems
  • Experience of working to deadlines and managing conflicting priorities
  • Experience working effectively in a team, influencing as appropriate

Skills

  • Attention to detail
  • Excellent organisational skills
  • Effective communication skills
  • Flexible and adaptable team player
  • Ability to think analytically

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Head of Quality Control (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria

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FIXED-TERM CONTRACT (1,5 years)

YOUR RESPONSIBILITIES

  • Site functional lead for Quality Control (QC) of marketed products. Lead and develop local site QC team Local line management responsibilities for QC Analytics (QCA) and Sample Management Departments (20 employees). Site Quality Control responsibilities including QC testing (release, stability, and raw material) and management of samples.
  • Coordinate in vivo experiments with Laboratory Animal Facility and ensure compliant set-up in vivo QC testing (release and stability).
  • Assure compliance with cGMP of all QC facilities, equipment, systems, and processes
  • Keep up to date with current GMP guidelines, relevant pharmacopoeia and scientific knowledge in respect to QC testing requirement and methods.
  • Technical oversight of tech transfer and all external QC testing activities.
  • Assure that external and internal regulations for Environment, Health and Safety are fulfilled for all QC staff, facilities, systems and processes.
  • Responsible for review/approval of QC test data, and QC-batch/sample result release, including trending, sample related deviations, Out of specification (OOS) and Out of control (OOC) investigation and timely escalation.
  • Responsible for providing technical expertise support from QC to investigations and technical matters.
  • Responsible for QCA test plans and internal QC resource planning to ensure timely delivery of QC results.
  • Responsible for defining and maintaining the direct cost budget for the QC cost centers
  • Review and approval of specifications, validation and qualification documents, as well as standard operation procedures of analytical methods and sample management
  • Responsible for QC employees to have the necessary qualification, practical experience and competency.
  • Responsible for premise and equipment to be maintained to suit its intended purpose

YOUR QUALIFICATIONS

  • Bachelor or Master Degree in Natural Sciences, with extensive work experience in the Life Science or Pharmaceutical Industry,
  • Minimum of 5 years’ work experience within GxP regulated Life Science or Pharmaceutical Industry
  • Experience of relevant GxP (GMP, GCP, GCLP) requirements for QC for the EU, US and Canadian markets in a commercial environment
  • Used to work in an international environment with various cultures is desirable
  • Strong management and leadership skills with ability to motivate and engage
  • Proactive, solution-oriented and able to react in a fast changing environment
  • Ability to manage and prioritize workload both for the organization as well as on a personal level
  • Business fluent in English and German

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 65.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

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Government & Public Affairs Manager (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

 

Job Summary

The UK Government and Public Relations Manager will be responsible for directing the Company’s policies and objectives regarding local, Scottish and UK government affairs. The incumbent will maintain strong relationships with government authorities and committees in order to protect and advance the Company’s interests, fielding all inquiries from government officials, including those related to the Company’s COVID-19 vaccine candidate. The Government and Public Relations Manager will also establish corporate strategies, policies and plans that align with evolving laws, regulations and standards.

The Government and Public Relations Manager will also be responsible for developing strong relationships with the UK media outlets and will ideally already have his own network of journalists.

In his role, the Government and Public Relations Manager will also support internal communications on the Company’s main manufacturing site in Livingston, Scotland.

To be successful, the Government and Public Relations Manager should be a highly articulate and excellent presenter with a deep understanding of public relations. The top candidate will be a strong communicator, capable of representing the Company effectively to government representatives, journalists and the public.

Responsibilities

  • Plan and execute local publicity
  • Develop and maintain relationships with public institutions, media and influencers in the vaccine space
  • Continue to build the VLA brand in the UK
  • Track campaign success and media coverage
  • Ensure brand consistency in all content
  • Address negative press or PR crises if they occur
  • Feed UK issues into global policy and messages

Experience

  • Advanced degree in Political Science, Communications, Marketing, Journalism, or another relevant field
  • 10+ years’ experience in public and/or government relations
  • Expert knowledge of UK, Scottish and local government functions

Required Skills

  • Excellent communication skills, both written and verbal
  • Established connections with media outlets
  • Expert knowledge of social media
  • Creative thinking with an affinity for innovation and problem-solving

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Key Account Manager Sverige (Solna, Sweden)

  • Position: Full time
  • Location: Solna, Sweden

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Vi söker en Key Account Manager Sverige med placering i Mälardalen.
Valneva är ett fransk-österrikiskt vaccinföretag, som specialiserat sig på utveckling och kommersialisering av profylaktiska vacciner mot infektionssjukdomar. Företagets vision är att bidra till en värld där ingen dör eller lider av en sjukdom som kan förebyggas av vaccination. Produktportföljen består i dagsläget av två kommersiella resevacciner, ett för förebyggande av japansk encefalit och ett för förebyggande av kolera.

Företaget har flera vaccinkandidater under utveckling, bland annat mot borrelia, covid-19 och chikungunya-viruset. Valneva Sweden AB är ett bolag där hela värdekedjan finns på plats i Solna.

Som nationell KAM ansvarar du för att driva försäljningsresultat och uppnå lönsamhetsmål. Du skapar och upprätthåller relationer med nyckelkunder och Key Opinion Leaders genom att använda både F2F- och digitala möten.
Rollen rapporterar till Head of Sales & Marketing Nordics.

Ansvarsområden:

  • Samarbeta med nyckelkunder och bidra med input till affärsplaner i syfte att säkerställa affärsmöjligheter.
  • Uppnå affärsmål avseende sälj och marknadsandelar.
  • Utveckla och implementera en ”Key Account Plan” för att uppnå överenskomna mål.
  • Identifiera utbildningsbehov hos kunder samt anordna utbildningar.
  • Förvalta och följa upp nyckelkunder utifrån överenskomna KPIer. (Key Performance Indicator)
  • Representera Valneva på Travel Health konferenser/möten.
  • Maximera värde och igenkänning av Valnevas produkter.

Erfarenheter:

  • Relevant akademisk utbildning inom naturvetenskap, hälsa eller ekonomi.
  • Du är mycket bra på att etablera, bygga och upprätthålla viktiga kundrelationer.
  • Du är proaktiv, drivande och har ett kommersiellt tankesätt.
  • Du är resultatorienterad och har förmåga att identifiera möjligheter samt hitta lösningar som skapar mervärde för kunden.
  • Du är en god förhandlare, stark kommunikatör både muntligt och skriftligt.
  • Du tar gärna egna initiativ samtidigt som du är en god lagspelare.
  • Du har en hög integritet samt följer företagets och läkemedelsbranschens policies och etiska regler.

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QC Technician (Analytical) (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Job Summary

To execute defined and trained Quality Control department tests for the release of raw materials, intermediate products and final products according to defined procedures and protocols and according with best cGMP work practices, Quality Standards and metrics. As well as assisting in the implementation and maintenance of policies for Quality Control department within Valneva. Carry out laboratory tasks as identified by QC department.

Responsibilities:

  • Execute analytical procedures, for testing of raw materials, intermediate products and final products, according to defined SOPs and protocols
  • Apply best cGMP work practices and techniques to test and release raw materials and product within specification
  • Ensure that all necessary training is complete in the procedures conducted, and operate in compliance with best cGMP working practices at all times
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of QC
  • Be accountable for the analytical laboratories being clean, tidy and well organised and in a state of continuous inspection readiness
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Ensure that at any time equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Support change controls, investigations and CAPA’s in the post diligent manner
  • Identify areas for continuous improvement and escalate those to the Head of QC
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Maintain adequate stocks of materials and equipment and laboratory consumables
  • Assist in monitoring and maintaining calibration status of all equipment within the Quality Control department
  • Calibration of pipettes and informing relevant personnel in a timely manner of any failure of calibration
  • Arrange subcontract of QC testing and dispatch to approved suppliers and provide support to the Logistics department
  • Assist in ensuring adequate stocks of material and equipment for effective operation of laboratories
  • Storage of in process, and final products samples including, for stability and retention purposes
  • Preparation of SOPs (where applicable) in accordance with Valneva Quality systems
  • Perform filing duties and other QC administrative duties as required by the line manager or Head of QC
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Shift work and out of hours work as required

Experience:

  • A minimum of 2 years’ experience working within a QC laboratory working to GMP within a recognised quality system
  • Writing and working to SOP documentation
  • Analytical methods experience, in a production-focused environment, in assays (not limited to) Haemagglutination assays, micro-plate assays such as ELISA and dye binding colorimetric assays (Bradford Method, Coomassie Plus), Electrophoresis, TVC and UV Spectrophotometry
  • Assay development, validation and transfer experience desirable
  • Experience of working within Quality Management Systems which include deviations, change controls and CAPA’s
  • Cell culture and Microbiological experience would be preferable
  • Plaque testing and ELISA experience highly desirable
  • Proven track record of being able to maintain the highest standards of hygiene and
    cleanliness in a laboratory environment
  • All round experience of working within a laboratory environment

Skills:

  • Capability to organise and schedule work within a busy laboratory
  • Knowledge of GMP guidelines and regulatory bodies
  • Well organised, self-motivated individual
  • Ability to follow instructions and manage workload to meet expected work schedules

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QC Coordinator (Logistics) (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Summary

Co-ordination of QC sample management, including shipments and supporting QC activities, in accordance with defined procedures, protocols and regulatory guidelines.

Responsibilities

  • Shipment of QC samples and materials, including viral samples, to approved external test houses according to defined procedures, schedules and in compliance with GMP and Dangerous Goods regulations including the preparation of shipment documentation and samples
  • Embrace a flexible way of working and respond efficiently to changes to the shipment schedule
  • Support co-ordination of the storage of QC samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
  • Support QC activities in line with manufacturing schedule as per QC rota. QC activities include sample receipt from Manufacturing and sample storage, calibration of balances, checking of labels, documentation review and occasional coverage of Total Viable Count testing. This includes provision of overtime cover as required, i.e. coverage of late and weekend QC rota, where required
  • Progress QMS in a timely manner, to ensure on-time delivery
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
  • Maintain all QC systems, databases, logs and support the generation of QC trend data
  • Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to line manager
  • Be accountable for the QC areas being clean, tidy and well-organised and in a state of continuous inspection readiness
  • Perform routine housekeeping activities in QC including cleaning of equipment and laboratory areas and maintenance of equipment including replenishment of liquid nitrogen tanks
  • Ensure that all required training is complete in procedures performed and operate in compliance with best cGMP working practices at all times
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Maintenance of GMP documentation, e.g. review and archiving
  • Shift work and out of hours work as required
  • Undertake any other duties in accordance with company requirements

Experience

  • Degree in biological sciences or relevant experience
  • Knowledge of GMP guidelines and regulatory bodies or biologics/vaccine background would be an advantage
  • Experience managing external relationships for effective delivery i.e. suppliers would be an advantage
  • Experience of Quality Management Systems would be an advantage
  • Experience of raw material testing, sample management and shipping would be an advantage
  • Experience of working to deadlines and managing conflicting priorities

Skills

  • Ability to organise and schedule work within a busy QC department
  • Experience of working to SOP documentation
  • Excellent time management and prioritisation skills
  • Ability to communicate at all levels
  • Flexible and able to efficiently adapt to organisational changes
  • Ability to utilise resources to solve problems
  • Strong attention to detail

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AX Manager (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Job Summary

The role will interface between Manufacturing, Supply Chain and Finance ensuring the AX Dynamics system is live with full responsibility for ensuring the system is up to date at all times and accurately reflects current process / stages of manufacture.

The Team manager AX oversees a team of highly skilled experts that operate Valneva’s global ERP system MS Dynamics AX.

This is a pivotal role and aligns with local (IT, finance, manufacturing, supply chain, quality) as well as global stakeholders to ensure proper set-up, operation and availability of the ERP system.

The ideal candidate is a skilled project manager, contributor and leader who ensures high-quality and compliant operations, while being flexible enough to respond to business opportunities and challenges.

Responsibilities:

  • Responsible for the support and operation of the AX2012 environment, liaises with local stakeholders (Finance, Manufacturing, Supply Chain) and the central AX team, ensures the proper set up and availability of the local AX system
  • Takes care of / supports changes to the system, definition (user requirements), implementation (with external partners), testing and go-live takes care about the user support (1st and 2nd level) of the AX system, liaises with external vendors to resolve any issues and document the issue resolution
  • Supports users with training, process related questions and possibilities to further improve the usage of the system (within area of expertise)
  • Creates, reviews and executes validation relevant documents according to GAMP5 (e.g. user requirements, design specifications, verification documents)
  • Liaises with and support the local and corporate IT team for and within ERP relevant topics and projects
  • Liaises with and supports the Quality Assurance (QA) for and within ERP relevant topics and projects
  • Leads the local AX support team
  • Sets up and chairs the local AX steering group, is a member of the global AX steering group
  • Ensures that all AX relevant questions are aligned with local and global stakeholders, AX relevant decisions are prepared and presented to the appropriate groups (local site exec, global committees)
  • Supports local and global stakeholders in the definition, setup and operation of computerized systems related or connected to AX and lead or support implementations within area of expertise

Experience includes:

  • Experience using an ERP system (preferably Microsoft AX)
  • Experience working in a GMP/GXP environment
  • Experience with Quality Management Systems
  • Experience working to deadlines and managing conflicting priorities
  • Experience developing, maintaining and implementing SOPs and other quality related documents

Key Skills:

  • Analytical, problem solver
  • Proactive individual
  • Strong communicator
  • Team player
  • Able to plan and prioritise
  • Excellent organisational skills

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SME Drug Product, Valneva (Solna, Sweden)

  • Position: Full time
  • Location: Solna, Sweden

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Valneva är ett vaccinföretag, baserat i Solna, som specialiserat sig på utveckling och kommersialisering av profylaktiska vacciner mot infektionssjukdomar där betydande ouppfyllda medicinska behov finns. Vår vision är att bidra till en värld där ingen dör eller lider av en sjukdom som kan förebyggas av vaccination.

I rollen som SME drug product i gruppen Validation & Manufacturing Support kommer du att arbeta på Valnevas två siter i Solna. Du kommer arbeta med frågor gällande produkternas formulering, aseptiska tillverkning samt avsyning och säkerställa att krav inom dessa områden uppfylls. Du kommer ha en drivande roll vid processvalideringar som sker vid exempelvis ombyggnation eller produktöverföring. Som SME kommer du ge input om produktpåverkan vid avvikelser, Change Controls samt riskbedömningar.

I denna roll ingår följande ansvar:

  • Säkerställa att kontinuerlig produkt-trendning utförs för övervakning av processers robusthet.
  • Vara drivande i processvalideringar och riskgranskningar kopplat till fyllningsprocessen, syning och formulering.
  • Föreslå och driva förbättringar.
  • Ta fram underlag för regulatorisk dokumentation.
  • Vara delaktig i avvikelseutredningar, CAPA och CC för produkt och process. Bedöma påverkan på produktkvalitet och utbyte.
  • Godkänna ändringar i batch-protokoll.
  • Delta vid inspektioner.

Om dig

Vi letar just nu efter en person som har längre erfarenhet av processvalidering för aseptisk tillverkning. Du är van att jobba tvärfunktionellt och är hjälpsam mot dina medarbetare.

För att trivas i den här rollen bör du vara serviceinriktad och en duktig kommunikatör för att kunna förstå och stötta organisationen med resultatinriktad problemlösning. Du är trygg i din roll och förmedlar information på ett trovärdigt, tydligt och enkelt sätt.

Du är van att jobba enligt Eudralex Annex 1 samt lokala SOP:ar och du har varit i branschen i några år där du har jobbat med liknande arbetsuppgifter. Du förstår att prioriteringar kan ändras och är flexibel och prestigelös.

Dina erfarenheter

  • Relevant naturvetenskaplig utbildning.
  • GMP.
  • Minst 5 års erfarenhet från aseptisk tillverkning och sterila produkter, företrädesvis flytande produkt i vial.
  • Framtagning och upprätthållande av kontrollstrategi för kommersiella produkter.
  • Riskgranskningar för material med produktkontakt.

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Valneva Standorte

Valneva hat Niederlassungen in Österreich, Schweden, dem Vereinigten Königreich, Frankreich, Kanada und den USA.

Österreich

Wien

VALNEVA Austria GmbH
Campus Vienna Biocenter 3
1030 Wien, Österreich
T: +43 1 20620 F: +43 1 20 620 800 Kontaktieren Sie uns

Canada

Montreal

Commercial Operations
3535 Saint-Charles Blvd.,
Suite 600
Kirkland, Québec H9H 5B9
Canada
T: +1 514 630 6999 F: +1 514 630 9666 Kontaktieren Sie uns

France

Nantes

6 rue Alain Bombard
44800 SAINT-HERBLAIN
France
T: +33 228 07 37 10 F: +33 228 07 37 11 Kontaktieren Sie uns

Lyon

Ilot Saint-Joseph
Bureaux Convergence Bâtiment A
12 ter quai Perrache
69 002 Lyon, France
T: +33 4 78 76 61 01 Kontaktieren Sie uns

Sweden

Solna

VALNEVA Sweden AB
SE – 105 21 Stockholm, Sweden

Visiting Address:
Gunnar Asplunds allé 16
171 69 Solna, Sweden
T: +46 (0)8 735 10 00 F: +46 (0)8 82 73 04

U.K.

Livingston

Valneva Scotland Ltd.
Oakbank Park Road
Livingston EH53 0TG
Scotland
T: +44 1506 446 600 F: +44 1506 446 601 Kontaktieren Sie uns

Fleet

Valneva UK Ltd
Commercial Operations
Centaur House
Ancells Business Park
Ancells Road / Fleet
Hampshire GU51 2UJ, United Kingdom
T: +44 1252 761007

U.S.A.

Gaithersburg

Valneva USA, Inc.
910 Clopper Road, Suite 160S
Gaithersburg, MD 20878, USA
T: +1 301 556 4500 Kontaktieren Sie uns