Our achievements are based on our Company's culture, which is characterized by respect, dedication and motivation.

We are Valneva

"I've managed to get a lot of skills since I joined the vaccine manufacturing team. It feels quite special to be a part of what's going on here."

Daniel, Manufacturing Technician in Scotland

“I am leading a team responsible for managing the Phase 2 clinical studies for our Lyme disease vaccine. It is truly exciting to watch the program develop and I am glad to be working with such a great team.”

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

“I feel fortunate that I can contribute to the fight against the COVID-19 pandemic with my work in Quality Control, where we make sure that each batch of vaccine is tested at every step of its journey.”

Michael, Technical Assistant in QC Analytics in Austria

"In Solna, I am leading the project of switching from producing the cholera vaccine to producing the vaccine candidate against COVID-19. I am really proud of the work the team has achieved here."

Susanna, Head of Manufacturing Support in Sweden

"Valneva is a fast-paced and versatile workplace, where you can feel the enthusiasm and really move things. Although everyone is very focused, you can easily approach colleagues, even across departmental and hierarchical boundaries."

Klaudia, Sales Manager Austria

"On the Scouting and Innovation team, we are looking for new vaccine candidates that Valneva could bring into its pipeline. As a scientist at Valneva, I am glad that my work allows me to contribute to the prevention of infectious diseases and make a difference in people’s lives."

Melissa, Head of Vaccine Scouting & Technology Evaluation in France

"No matter if you work in research, manufacturing, administration or IT, the key to collaboration is a constructive and appreciative dialogue between colleagues. At Valneva, you will find challenging assignments, a multicultural environment, and a clear commitment to ethics, compliance and integrity."

Douglas, Senior Systems Administrator in Scotland

"It is a pleasure to work with these talented people at Valneva in Sweden, where we are currently expanding our capacity in order to provide full fill and finish operations for our COVID-19 vaccine candidate."

Robert, Director of Manufacturing Operations in Sweden

Valneva’s success stems from the dedication and expertise of approximately 700 employees. Valneva is an international company that prides itself in providing its workforce the opportunity for personal growth and development, while encouraging work-life balance. As a global company that respects all cultures, we are convinced that the rich diversity of our colleagues makes us more innovative, effective and competitive.

Current Job Openings

Sales Assistant (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

  • Organisatorische & administrative Unterstützung des Teams und anderen Stakeholdern
  • Betreuung von ad hoc Projekten
  • Verwaltung des Promotionsmaterials sowie Verantwortung für die Verteilung dessen nach unseren vordefinierten Standardprozessen
  • Administration von Genehmigungs- und Compliance Prozessen betreffend des Promotionsmaterials
  • Durchführung von Bestellungen und Rechnungsprüfung
  • Unterstützung des Teams beim Vertragsmanagement und bei der Aufrechterhaltung der Kontakte zu externen Agenturen und medizinischen Fachkräften/Organisationen
  • Koordination abteilungsübergreifender Themen mit der Einkaufs-, Compliance- und Rechtsabteilung
  • Unterstützung in der Kundenbetreuung

IHRE FÄHIGKEITEN

  • Erfolgreich abgeschlossene kaufmännische Ausbildung (BSc) mit Schwerpunkt Kommunikation/Marketing von Vorteil
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Sehr gute MS Office Kenntnisse
  • Eigenständiger, genauer sowie lösungsorientierter Arbeitsstil mit Innovationsgedanken
  • Ausgezeichnete soziale Kompetenz und Kommunikationsfähigkeit
  • Flexible Teamplayer/in
  • Positive und verlässliche Persönlichkeit
  • 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 39.200,- brutto pro Jahr (Vollzeitbasis) gilt.

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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 needValneva 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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Head of SCM (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 needValneva 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 at Valneva Scotland for a Head of Supply Chain Management.

Job Summary

To ensure an integrated and compliant supply chain is managed, including the supply of all goods, services and material activities. Ensuring compliance with lower costs and best quality according to the business, performance and compliance requirements. Defined internal and external regulations with the aim to reliably supply the products, materials and services to the internal and external customers on time. Supporting Valneva Scotland Ltd and Valneva UK business requirements.

Responsibilities

  • As part of the management team, contribute to the site performance as agreed through the performance management objectives
  • To leverage strategic procurement / contract management and cost drivers
  • Ensure that Supply Chain Management plans and activities are cross-functionally communicated and aligned and delivered to agreed sales and operations targets on time, are cost effective and according to the quality standards defined by internal and external regulations
  • Responsibility to control and deliver against an agreed annual Supply Chain Management budget and monitor monthly statistics and compare to projected figures
  • Oversee that all internal and external Supply Chain Management activities in respect of materials management and the MPS for manufacture of Valneva UK / Scotland products, are carried out in compliance with applicable cGMP standards, techniques and best practice
  • Ensure that all SCM staff are appropriately trained and competent in the procedures they are conducting and are in compliance with best cGMP working practices at all times
  • 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
  • Ensure that deviations to compliance (Quality and HSE) or business metrics are escalated to the Head of Corporate Supply, Planning & Logistics and managed through change controls, investigations and CAPA’s in an appropriate, timely fashion and in alignment with Quality Operations
  • Actively lead the development and maintenance of an enthusiastic, supportive and collaborative environment across the site and within the function
  • Develop a risk management strategy and maintain a business continuity plan to include dual sourcing of all outsourced activities and suppliers
  • Improve strategies for inventory control and stock management to ensure that both are highly visible and meet operational requirements
  • Integrate SCM activities and planning with other internal and external operational procedures across the site (e.g. BOM) to optimise materials usage, eliminate waste and reduce COG’s where possible
  • Manage external suppliers to ensure effective business relationships are maintained and translate into required level of service and best prices obtained
  • Managing external contractors to agreed terms of engagement and service level agreements, ensuring costing meets business requirements
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience

  • Technical degree (BSc / MSc) or relevant experience
  • Relevant cross-functional work experience in the biotechnology or pharmaceutical industry regulated by FDA & EMEA, ideally in vaccines
  • Strong leadership skills and experience with the ability to motivate and drive an organisation through major change management processes
  • Excellent management skills and experience with proven track records on project and continuous improvement initiatives Commercial manufacturing experience, preferably in vaccines

Required Skills

  • Strong facilitation, communication and organisational skills
  • Self-motivated, energetic and value-driven
  • Clear communicator with strong leadership skills
  • Ability to motivate, influence and drive team delivery
  • Proven decision-making ability, whilst considering wider site implications

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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 needValneva 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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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 needValneva 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 needValneva 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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Stability Coordinator (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 needValneva 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

  • Manage stability program for market products
  • Contribute to and review stability protocols
  • Establish trending sheets/rules and statistical analysis for stability and release data
  • Keep overview on assay performance trending sheets
  • Maintain documentation for stability samples and trending
  • Serve as QC point of contact for installation of stability and trending software, including drafting of design and user requirements, oversee and support execution of software validation and implementation
  • Responsible for placing samples on stability, pulling samples, ensuring completion of testing, recording tracking and trending of test results
  • Initiating and completing deviations, CAPAs, OOS, OOC, laboratory investigations, and Change Controls as needed
  • Perform testing as needed
  • Strong knowledge of cGMP, Quality systems, and ICH / regulatory guidance

YOUR QUALIFICATIONS

  • Bachelor, Master Degree or equivalent in a relevant field (e.g. Biotechnology, Bioengineering, Chemistry, Molecular Biology, Biology)
  • Experience with setting up and coordinating stability studies
  • Experience with trending of results
  • Experience with statistical analysis of data
  • Knowledge of relevant guidelines
  • Experience with deviations, changes and preparation of reports
  • Background knowledge on assays performed for stability studies
  • Team work and excellent organizational skills
  • Fluent in English (oral and written), fluent in 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

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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(Junior) Scientist Clinical Serology (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 needValneva 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

  • Supervise development and validation of immunological assays
  • Supervision of GCLP-compliant immunogenicity testing for clinical trials (scientific, technical and organizational aspects)
  • Assay planning, analysis, review, as well as assay maintenance and trouble shooting
  • Writing technical protocols/reports (Assay development and validation, Analytical Plans and Reports) and other GxP documentation
  • Evaluation and presentation of data
  • Provide expertise and support to other functions within the organization
  • Establish, maintain and supervise collaborations with external partners

YOUR QUALIFICATIONS

  • PhD in the fields of Immunology, Virology and/or Microbiology
  • Work experience in the life science industry or experience with clinical studies is a plus
  • Hands-on experience on immunological/biological assays/analytical methods (e.g. ELISA, cell based assays, RT-qPCR)
  • Knowledge in development of assays
  • Experience in an GxP environment is a plus
  • Excellent analytical/problem solving skills
  • Strong organizational and communication skills
  • Fluent English
  • Good presentation techniques
  • Able and used to work under time pressure on multiple projects in a changing environment

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

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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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 needValneva 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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Scientist Analytical Development (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

  • Coordination of Analytical Transfer to external Partner (including material shipment, trainings, summary of data etc.)
  • Interface between internal SMEs and external Partner, ensuring efficient communication and information dissemination with the department, cross-department and with external partner
  • Ensure compliance with internal and external procedures (e.g. international GMP requirements), legal and regulatory requirements
  • Ensure timely completion of milestones according to project plans by e.g. pro-active follow up and timely delivery of action items.
  • Be familiar with the analytical methods to be transferred
  • Accurately summarize and present results of studies internally and externally
  • Become an integral part of highly interactive team working on multiple projects

YOUR QUALIFICATIONS

  • University degree in relevant scientific field
  • Work experience in the life science environment
  • Background in analytical and immunological/microbiological methods applicable to vaccines
  • Good understanding of current Good Manufacturing and Good Laboratory Practices (GMP, GLP), ICH guidance for quality practices and well as other pharmaceutical regulatory guidelines, especially related to the biotechnology industry and analytical transfers
  • Ability to work according to challenging timelines
  • Team work, excellent organizational skills
  • Advanced presentation skills for various stakeholders and audiences
  • Computer software (MS Office ..) and knowledge in statistical analyses
  • Fluent in English (oral and written), fluent in 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

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 48.000,- 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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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 needValneva 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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Sterilization Processes (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 Sterilization Processes i gruppen Validation & Manufacturing Support så kommer du att få möjlighet att arbeta med utrustning på Valnevas två siter i Solna, varav den ena är helt nybyggd. Som SME Sterilization Processes kommer du att arbeta med processfrågor som rör sterilisering. Du kommer att vara vår expert på autoklaver och övrig utrustning som används för sterilisering. I denna roll kommer du att arbeta med både förbättringsarbete inom ditt område på befintlig utrustning samt vara delaktig vid kravställning, inköp och kvalificering av ny utrustning eller vid ombyggnation.

I denna roll ingår följande ansvar:

  • Utföra kvalificering samt re-kvalificering av autoklaver och utrustning som används vid aseptisk tillverkning.
  • Utföra riskanalyser och bedöma hur en ändring påverkar steriliseringsprocesser.
  • Felsökning av utrustning som används vid aseptisk tillverkning.
  • Vara delaktig och/eller drivande vid avvikelseutredningar, ändringsärenden samt CAPA för verksamheten.

Om dig

Vi letar efter en person som har längre erfarenhet av sterila processer, aseptiskt arbetssätt och utrustningar som används för att uppnå detta. Du är van att jobba tvärfunktionellt och självdriven.

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

Du är van att jobba enligt regelverk och har jobbat med sterila tillverkning i några år där du har jobbat med liknande arbetsuppgifter och utrustningar. Du förstår att prioriteringar kan ändras och är flexible och prestigelös. Du gillar att jobba praktiskt såväl som teoretiskt och är öppen för nya sätt att lösa problem på.

Dina erfarenheter

  • Naturvetenskaplig utbildning, gärna inom mikrobiologi eller liknande.
  • Erfarenhet av att kvalificerings samt re-kvalificering av autoklaver.
  • Erfarenhet av att utföra temperaturmappning med KEY Validator (eller likvärdigt system).
  • Erfarenhet av att ta fram lastmönster för autoklav.
  • Meriterande med erfarenhet av aseptisk tillverkning och sterila produkter.
  • Meriterande med GMP men du kan även komma från liknande bransch så som Medtech.

Ansökning

Är du intresserad? Senaste ansökningsdag är 23/1, men urval sker löpande så vänta inte för länge innan du ansöker!

Frågor? Du är varmt välkommen att kontakta Talent Advisor Linnéa Andersson på telefon: 072 888 65 77 eller email: linnea.andersson@mpyascitech.com

Om Valneva

Valneva Sweden AB är den svenska delen av Valneva som har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med runt 700 anställda. Valneva har flera vaccinkandidater under utveckling, bland annat mot Borrelia, COVID-19 och chikungunya. På Valneva Sweden AB i Solna sker tillverkning och distribution av våra kommersiella resevacciner samt tillverkning av kliniskt prövningsmaterial. 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 Valnevabolag runt om i världen.

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Datoriserade system (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 Datoriserade System i gruppen Validation & Manufacturing Support på Valneva så kommer du att få möjlighet att arbeta med utrustning på Valnevas två tillverknings-siter i Solna, varav den ena är helt nybyggd. Som SME inom datoriserade system kommer du vara länken mellan utrustningsansvarig/systemägare och IT. Du får möjligheten att jobba med både förbättringsarbete inom ditt område på befintlig utrustning samt vara delaktig vid inköp av ny utrustning med kravställning.

I denna roll ingår följande ansvar:

  • Kravställa datoriserade system vid inköp av ny produktionsutrustning.
  • Ta fram protokoll för kvalificering av datoriserade system.
  • Felsökning av befintliga system.
  • Förbättringar av användarvänligheten.
  • Utföra periodisk granskning av datoriserade system.
  • Genomgång av audit trail samt behörigheter.
  • Vara delaktig och/eller drivande vid avvikelseutredning, CC samt CAPA.

Om dig

Vi letar just nu efter en person som är kompetent när det gäller datoriserade system. Som person är du tekniskt intresserad med en fallenhet för att förstå datoriserade system och hur inställningar påverkar inte bara GMP utan även användarvänligheten för operatören.

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

Vi tror att du arbetat inom life science några år. Du är van att jobba enligt 21 CFR Part 11 och Eudralex Annex 11 samt lokala SOP:ar. Du förstår att prioriteringar kan ändras och är flexibel och prestigelös. Du är kommunikativ och gillar att jobba i team såväl som individuellt.

Dina erfarenheter

  • Naturvetenskaplig eftergymnasial utbildning eller lång branscherfarenhet.
  • GMP
  • 21 CFR Part 11 och EudraLex Annex 11
  • Erfarenheter av kvalificering av datoriserade system
  • Goda kunskaper i tal och skrift i Svenska och Engelska
  • Meriterande med erfarenhet av SCADA och/eller CHOCOS
  • Meriterande med erfarenhet av Visionsystem (exempelvis Antares) samt serialiseringssystem

Ansökning

Är du intresserad? Senaste ansökningsdag är 16/1, men urval sker löpande så vänta inte för länge innan du ansöker!

Frågor? Du är varmt välkommen att kontakta Talent Advisor Linnéa Andersson på telefon: 072 888 65 77 eller email: linnea.andersson@mpyascitech.com

Om Valneva

Valneva Sweden AB är den svenska delen av Valneva som har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med runt 700 anställda. Valneva har flera vaccinkandidater under utveckling, bland annat mot Borrelia, COVID-19 och chikungunya. På Valneva Sweden AB i Solna sker tillverkning och distribution av våra kommersiella resevacciner samt tillverkning av kliniskt prövningsmaterial. 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 Valnevabolag runt om i världen.

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Contamination Control (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- Contamination Control i gruppen Validation & Manufacturing Support kommer du att få möjlighet att arbeta på Valnevas två siter i Solna, varav den ena är helt nybyggd. Som SME Contamination Control kommer du att jobba med frågor som rör produktionshygien. Du kommer att ansvara över Contamination Control Strategy och säkerställa att anläggningarna håller den förväntat höga standard som krävs för aseptisk tillverkning. Du kommer att få möjligheten att arbeta med både förbättringsarbete inom ditt område på befintlig utrustning och lokaler samt vara delaktig vid kravställning, inköp och kvalificering av ny utrustning eller vid ombyggnation.

I denna roll ingår följande ansvar:

  • Ansvara för siternas Contamination Control Strategy.
  • Säkerställa att instruktioner och dokument för produktionshygien håller den standards som krävs för aseptisk fyllning i enlighet med cGMP
  • Kravställning, inköp och kvalificering av utrustning samt renrum.
  • Vara delaktig och/eller drivande vid avvikelseutredning, CC samt CAPA rörande produktionshygien och aseptik.

Om dig

Vi letar just nu efter en person som har längre erfarenhet av contamination control, aseptik och produktionshygien 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 vart i branschen i några år där du har jobbat med liknande arbetsuppgifter. Du förstår att prioriteringar kan ändras och är flexible och prestigelös.

Dina erfarenheter

  • Naturvetenskaplig utbildning, gärna inom mikrobiologi.
  • GMP
  • Vara införstådd i samt van att arbeta enligt EduraLex annex 1 samt lokalt uppsatta SOP:ar
  • Erfarenhet av aseptisk tillverkning och sterila produkter.
  • Meriterande att ha jobba i renrum samt utfört renrumskvalificering(ar)
  • Meriterande med erfarenhet av att ta fram samt upprätthålla contamination control strategy
  • Meriterande med erfarenhet av produktionshygien.
  • Meriterande med erfarenhet av mediafyllning.
  • Meriterande med erfarenhet av luftrörelsevisualisering.

Ansökning

Är du intresserad? Senaste ansökningsdag är 16/1, men urval sker löpande så vänta inte för länge innan du ansöker!

Frågor? Du är varmt välkommen att kontakta Talent Advisor Linnéa Andersson på telefon: 072 888 65 77 eller email: linnea.andersson@mpyascitech.com

Om Valneva

Valneva Sweden AB är den svenska delen av Valneva som har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med runt 700 anställda. Valneva har flera vaccinkandidater under utveckling, bland annat mot Borrelia, COVID-19 och chikungunya. På Valneva Sweden AB i Solna sker tillverkning och distribution av våra kommersiella resevacciner samt tillverkning av kliniskt prövningsmaterial. 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 Valnevabolag runt om i världen.

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Cleaning Validation (Solna, Sweden)

  • Position: Full time
  • Location: Solna, Sweden

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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.

I rollen som SME Cleaning Validation i gruppen Validation and Manufacturing Support på Valneva så kommer du att få möjlighet att arbeta med utrustning på Valnevas två siter i Solna, varav den ena är helt nybyggd. Som SME Cleaning Validation kommer du att jobba med att utföra och säkerställa att den utrustning som är produktrörande blir helt ren och att korskontamination ej sker mellan de olika batcherna och produkterna. Du kommer arbeta med flera olika produkter i flera olika processteg. Detta omfattar områden som USP/fermenteing av bakterier, DSP/proteinrening såväl som formulering och fyllning av inaktiverade bakteriella och virala produkter.

I denna roll kommer du att få möjlighet att jobba med både förbättringsarbete inom ditt område på befintlig utrustning samt vara delaktig vid kravställning, inköp och kvalificering av ny utrustning.

I denna roll ingår följande ansvar:

  • Kravställning, inköp och kvalificering av produktionsutrustning
  • Säkerställa att cGMP efterlevs
  • Vara delaktig och/eller drivande vid avvikelseutredningar, CC ärenden samt CAPA Vid behov leda/driva projekt eller aktiviteter inom området cleaning

Om dig

Vi letar just nu efter en person som har längre erfarenhet av Cleaning Validation.

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

Du är van att jobba enligt Eudralex Annex 15 samt lokala SOP:ar och du har verkat inom life science branschen i några år och skaffat dig en praktisk erfarenhet. Du förstår att prioriteringar kan ändras och är flexibel och prestigelös.

Dina erfarenheter

  • Naturvetenskaplig eftergymnasial utbildning,
  • Erfarenhet av GMP
  • Praktisk erfarenhet av att ha arbetat med cleaning validation
  • Vara införstådd i samt van att arbeta enligt EduraLex annex 15 samt lokalt uppsatta SOP:ar

Ansökning

Är du intresserad? Senaste ansökningsdag är 23/1, men urval sker löpande så vänta inte för länge innan du ansöker!

Frågor? Du är varmt välkommen att kontakta Talent Advisor Linnéa Andersson på telefon: 072 888 65 77 eller email: linnea.andersson@mpyascitech.com

Om Valneva

Valneva Sweden AB är den svenska delen av Valneva som har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med runt 700 anställda. Valneva har flera vaccinkandidater under utveckling, bland annat mot Borrelia, COVID-19 och chikungunya. På Valneva Sweden AB i Solna sker tillverkning och distribution av våra kommersiella resevacciner samt tillverkning av kliniskt prövningsmaterial. 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 Valnevabolag runt om i världen.

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Commercial Coordinator (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.

Commercial Coordinator (f/m/d)

100%, indefinite duration, as soon as possible

YOUR RESPONSIBILITIES

  • Provide administrative and organizational support to the Commercial Team and other identified stakeholders
  • Manage ad hoc projects whenever requested
  • Manage stock of promotional material and take responsibility for the distribution of material following our standard operating procedures
  • Administering promotional approvals and compliance processes for associated materials
  • Create purchase orders and monitoring invoices
  • Support team in handling contracts and liaise with external agencies and health care professionals and/or organizations
  • Coordinate cross-functional team efforts with procurement, compliance and legal
  • Assist in customer interactions as needed

YOUR QUALIFICATIONS

  • Bachelor’s degree in economics (marketing / communication would be an asset) with good experience in a supportive function in a commercial organization, preferably within Life Sciences
  • Fluent English and German with strong verbal and written skills
  • Proficiency with standard Windows and Office programs
  • Must be able to work well independently under the general guidance of the manager
  • Organized with strong systematic approach to prioritization
  • Solution-focused working style and ability to develop innovative ideas
  • Excellent interpersonal skills and ability to work flexibly in a small and focused team
  • Positive and accountable personality

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 € 39.200,- 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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Associate Clinical Operations Manager (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

  • Proactive support of all aspects of one or more Phase 1-4 clinical studies (for chikungunya vaccine development)
  • Support in the implementation of clinical studies from start-up to study completion
  • Contribution to the development of study relevant documents in the project development cycle
  • Support in CRO/vendor selection process and CRO/vendor oversight
  • Monitoring and execution of all study activities in compliance with ICH-GCP and FDA/EMA/MHRA requirements
  • Cross-functional collaboration with internal and external stakeholders (e.g. CROs)
  • Support in budget planning and financial tracking

YOUR QUALIFICATIONS

  • Academic education, Master or PhD degree (Life Science)
  • At least 1 year of relevant experience as a CRA in the pharma/life science industry
  • Project management experience is an advantage
  • Ideally experience in the field of vaccine development as well as supervision of CROs and CRAs
  • Team oriented, stress resistant personality
  • Strong communication and organizational skills
  • Ability to prioritize and maintain oversight
  • Very good command of English (spoken and written)

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 € 50.000,-  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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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 needValneva 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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Assistant(e) Commercial(e) – Lyon, France

  • Position: Full time
  • Location: Lyon, France

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Valneva est une société spécialisée dans le développement et la commercialisation de vaccins prophylactiques contre des maladies infectieuses générant d’importants besoins médicaux. Le Groupe a mis à profit son expertise et ses infrastructures pour commercialiser avec succès deux vaccins et pour faire rapidement progresser un large éventail de candidats vaccins en développement clinique, et notamment ses candidats vaccins contre la maladie de Lyme, la COVID-19 et le virus du chikungunya.

Valneva compte plus de 700 salariés et exerce ses activités depuis l’Autriche, la Suède, la Grande-Bretagne, la France, le Canada et les Etats-Unis.

Nous recherchons un(e) Assistant(e) Commercial(e) en CDI pour renforcer notre équipe basée à Lyon. Sous la direction du Directeur des Opérations Commerciales France & Benelux, vous assurerez les missions principales suivantes :

  • Assurer la prise en charge et le suivi des demandes clients (appels entrants, emails, courriers)
  • Gérer la base de données clients et fournir toute analyse pour la France et le Benelux (segmentation)
  • Gérer l’inventaire (disponibilité des produits) et veiller à l’acheminement vers les distributeurs
  • Piloter le processus de création des supports promotionnels (via la plateforme VEEVA / Promomats)
  • Assister aux briefing avec les agences de communication/marketing
  • Suivre les dates de validité du matériel promotionnel avec le Pharmacien Responsable
  • Structurer et coordonner un système d’archivage pour les opérations commerciales françaises, en lien avec le Pharmacien Responsable et le département juridique
  • Contribuer aux projets d’événements commerciaux
  • Contribuer à la fiabilité des outils de reporting commercial et fournir des rapports sur les indicateurs clés
  • Participer à la préparation des dossiers d’appels d’offres et mettre à jour l’outil de suivi
  • Suivre les factures, faire des demandes de paiement et répondre aux sollicitations du département Finance Comptabilité
  • Contribuer à l’élaboration des contrats, des accords et des déclarations de transparence (DMOS) en collaboration avec le département juridique
  • Assurer un rôle d’office manager pour le site de Lyon en collaboration avec les équipes Facility Management et IT.

Les missions qui vous seront confiées pourront évoluer, cette liste n’est pas exhaustive.

Profil

  • Titulaire d’un diplôme BAC à BAC+2 type Commerce / Gestion
  • 5 ans minimum d’expérience dans la vente au sein d’une entreprise de biotechnologies ou de l’industrie pharmaceutique
  • Expérience en gestion de distributeurs
  • Sens de l’organisation, capacité à gérer des demandes multiples et esprit d’initiative
  • Solides compétences en communication verbale et écrite
  • Excellente connaissance de MS Office
  • Connaissance des pratiques de conformité réglementaire
  • Capacité à communiquer en anglais serait un plus

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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 needValneva 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 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

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Supply Chain 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 needValneva 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 at Valneva Scotland for a Supply Chain Co-ordinator within our SCM Procurement Department.

Job Summary

As the Supply Chain Co-ordinator will work in association with the Procurement Co-ordinator by supporting the Buyers in our busy Procurement Department undertaking general administration duties in line with departmental and organisational Standard Operating Procedures (SOPs).

Responsibilities will include, but not be limited to:

  • Assist the Procurement Co-ordinator in placing all planned purchase orders (POs) with external suppliers via the Company ERP system
  • Assist in placing POs for all other purchases, as and when requested
  • Electronically file all PREQs and associated POs and quotes
  • Support suppliers with PO queries
  • Run reports for outstanding orders, non-confirmed orders etc.
  • General filing & housekeeping
  • Provide monthly KPI reports to management
  • Assist Buyers with data input to contract registers
  • Resolve and respond to any invoice queries received from Finance
  • Any additional tasks requested by line management

Experience

  • Previous experience in an administration role
  • Proven track record of all general administration duties e.g. filing, updating documents and spreadsheets etc.

Required Skills

  • Good MS Office skills
  • Good attention to detail
  • Familiarity with an integrated Enterprise Resource Planning (ERP) system would be beneficial but not essential as training will be given
  • Desire to develop and grow as the company expands

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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 needValneva 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 needValneva 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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QC Coordinator – Raw Materials (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a speciailty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva 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.

A full-time opportunity has arisen at Valneva Scotland for a QC Coordinator (Raw Materials) to join the team.

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 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

  • 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 Laboratory Manager
  • 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 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
  • 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 laboratory manager or Head of QC
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience includes: 

  • Degree in chemical/biological sciences or relevant experience
  • Knowledge of usage of Pharmacopoeias
  • 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 required:

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

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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 needValneva 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 needValneva 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 needValneva 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 needValneva 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 needValneva 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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Regulatory Affairs Manager (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria

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100%, as soon as possible, limited for 3 years

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva 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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Technicien(ne) Recherche et Développement Préclinique (Nantes, France)

  • Position: Full time
  • Location: Nantes, France

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Key Responsibilities

Nous recherchons un(e) Technicien(ne) R&D Recherche Préclinique en CDI pour renforcer notre équipe basée à Saint-Herblain (Nantes). Sous la direction du Responsable Recherche Préclinique France, vous assurerez les missions principales suivantes :

  • Organiser et réaliser des expériences lors des développements de procédés de purification des candidats vaccinaux
  • Réaliser les opérations de préparation des tampons conformément aux instructions
  • Réaliser les opérations de nettoyage des équipements conformément aux instructions
  • Assurer la gestion des stocks de matériels et réactifs propres aux expériences en collaboration avec l’équipe Logistique.
  • Effectuer les opérations de nettoyage, de démontage et de maintenance spécifique des colonnes de chromatographie
  • Réaliser des opérations de purification telles que la filtration en profondeur/tangentielle, chromatographie sur AKTA, filtration stérilisante.
  • Réaliser des opérations analytiques telles que le dosage protéiques (ex : UV, BCA, ELISA), SDS-PAGE, HPLC, western Blot, test d’endotoxines.
  • Proposer et réaliser des expériences en vue d’optimiser les protocoles en place ou lors de la mise en place de nouvelles techniques.
  • Participer au traitement et vérifier la cohérence des données. Alerter le superviseur en cas de valeurs anormales.
  • Rédaction du cahier de laboratoire suivant les procédures appropriées : renseigner les séquences des expériences, les analyses des résultats et les observations scientifiques.
  • Rédaction des instructions, de protocoles et de rapports techniques pour assurer la transmission du savoir-faire.
  • Respect des normes d’assurance qualité et des règles d’hygiène, de sécurité, de confinement biologique et la confidentialité applicable à Valneva.
  • Contribution à l’entretien et au bon fonctionnement de l’équipement et du matériel de laboratoire.
  • Participation active à la vie de l’équipe.

Profile

  • Licence bio-industries, biotechnologies ou autre formation avec dominante de développement de procédés de production/purification.
  • Cinq années minimum d’expérience dans une entreprise de biotechnologies ou pharmaceutique.
  • Qualifié(e) dans le domaine de la purification et techniques biochimiques (des compétences en virologie et biologie moléculaire seraient un plus).
  • Autonomie dans l’organisation, la réalisation des expériences et l’analyse des résultats.
  • Maîtrise des logiciels (Word, Excel, Power Point).
  • Maîtrise de l’anglais indispensable : compréhension et expression écrite et orale.
  • Flexible, curieux(se), ayant l’esprit d’équipe, attiré(e) par la découverte et les nouveaux défis

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Expert(e) Qualité (Nantes, France)

  • Position: Full time
  • Location: Nantes, France

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Nous recherchons un(e) Expert(e) Qualité en CDI pour renforcer notre équipe basée à Saint-Herblain (Nantes). Sous la direction de la Directrice Qualité France, vous assurerez les missions principales suivantes :

  • Coordonner le cycle de vie de la documentation incluant :
    Le maintien du système de management de la qualité (SMQ) de VALNEVA France SE (site de Nantes) en accord avec les politiques qualité du groupe et le code de la santé publique.
    L’amélioration du Système de Management de la Qualité (SMQ) : Passer en revue les politiques existantes et faire des suggestions de changements et d’améliorations et la façon de les mettre en oeuvre/ mesurer la performance et identifier toute zone de faiblesse, recommander et mettre en oeuvre des améliorations.
    Gestion des archives
  • Organiser et suivre la formation et les habilitations des collaborateurs selon leurs missions et fournir aux équipes des outils et techniques permettant l’atteinte des normes de qualité.
  • Participer à la mise en place et aux mises à jour de l’analyse des risques en étroite collaboration avec l’expert HSE.
  • Piloter la gestion des déviations, des incidents et des Plan d’Actions Correctives et Préventives (CAPA).
  • Gérer les audits internes en collaboration avec le Département Qualité Groupe Valneva.
  • Gérer et suivre la qualification des fournisseurs.
  • Créer et suivre les Indicateurs Clés de Performance (ICP) qualité.
  • Promouvoir une démarche qualité auprès des acteurs internes et externes et contrôler sa mise en oeuvre.
  • Alerter la hiérarchie en cas d’événement critique.
  • Gérer la signature et l’archivage des cahiers de laboratoire.
  • Fournir un support qualité à Valneva France SAS (filiale commerciale) :
    • sur la révision de documents qualité
    • la gestion des déviations, CAPAs
    • la réalisation d’analyses de risques

Profil

  • Master en Assurance Qualité.
  • Trois années minimum d’expérience en assurance qualité ou au sein d’un département lié à la qualité d’une entreprise de biotechnologie ou pharmaceutique.
  • Connaissance des normes GxP et des réglementations et directives en matière de pharmacovigilance.
  • Excellent sens de l’organisation et des responsabilités (gestion des priorités et des délais).
  • Parfaite compréhension des sujets de santé publique ou d’environnement liés à notre activité.
  • Maîtrise de l’anglais indispensable : compréhension et expression écrite et orale.
  • Capacité à faire preuve d’indépendance, d’objectivité, d’éthique et de confidentialité.

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Senior 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, 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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(Senior) Clinical Operation Specialist (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

  • Management of clinical study documents, including overseeing TMF-activities and creating, maintaining and filing sponsor study files in a timely manner
  • Track study activities, e.g., CRA monitoring visits, essential documents, and study site correspondence; review monitoring reports
  • Track regulatory documentation as required by national regulatory authorities
  • Serve as a liaison with purchasing department to ensure adequate supplies are ordered
  • Assist in management of shipments of investigational materials, site supplies or clinical samples and coordinate with Clinical Operations Manager, internal stakeholders and external vendors
  • Assist in study site/vendor payment procedures
  • Conduct Clinical Operations tasks in accordance with applicable Quality Systems
  • Assist in management of internal and external risk assessments and any corrective/preventative actions
  • Support Clinical Operations team with study-specific tasks as needed

YOUR QUALIFICATION

  • At least 3 years of relevant experience as a CTA in the pharma/life science industry, CRA experience is of advantage
  • Team oriented, stress resistant personality
  • Strong communication and organizational skills
  • Ability to prioritize and maintain oversight
  • Very good command of English (spoken and written)

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 € 42.000,-  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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Associate Clinical Operations Manager (Covid-19 or Lyme) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria

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100%, as soon as possible, limited for 18 months

Your responsibilities

  • Proactive support of all aspects of one or more phase 1-4 clinical studies (for Covid-19 vaccine or for Lyme vaccine development)
  • Support in the implementation of clinical studies from start-up to study completion
  • Contribution to the development of study relevant documents in the project development cycle
  • Monitoring and execution of all study activities in compliance with ICH-GCP and FDA/EMA/MHRA requirements
  • Cross-functional collaboration with internal and external stakeholders (e.g. CROs)
  • Support in budget planning and financial tracking

Your qualifications

  • Academic education, Master or PhD degree (Life Science)
  • At least 1 year of relevant experience as a CRA in the pharma/life science industry
  • Project management experience is an advantage
  • Ideally experience in the field of vaccine development as well as supervision of CROs and CRAs
  • Team oriented, stress resistant personality
  • Strong communication and organizational skills
  • Ability to prioritize and maintain oversight
  • Very good command of English (spoken and written)

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 € 50.000,-  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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Associate Clinical Strategy Manager – Covid-19 Project (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 needValneva 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

  • Provide medical writing for clinical and regulatory documents
  • Participate in development of clinical study documents and take over individual clinical study tasks after respective training
  • Support clinical study data analysis and interpretation of clinical trials
  • Organize advisory boards and study committees (Scientific Advisory Boards, DSMBs, Endpoint Adjudication Committees, etc.)
  • Conduct and summarize literature searches and competitive landscape reviews to support decisions on study designs, endpoints, assays, etc.

Your Qualifications

  • PhD in Life Sciences, preferably in Pharmacy or Biology/Molecular Biology; applicants with a Master’s degree and relevant professional experience are also invited to apply
  • Ideally either thesis in an area related to clinical development, vaccines, infectious diseases or immunology, or initial professional experience with clinical development at a CRO or sponsor
  • Strong writing skills
  • Analytical and detail-oriented mind-set
  • Excellent command of English as the main working language
  • Self-organized work style
  • Scientific interest in clinical development of vaccines

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 flextime, 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 € 50.000 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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Senior Project 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. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. 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. 

We are looking for a Senior Project Manager to join our team in Vienna:

YOUR RESPONSIBILITIES

  • Responsible for setting-up, monitoring and management of assigned projects (including Valneva development projects like for example COVID-19, clinical trials, as well as general project management activities) from initiation through completion conduct with a primary focus on milestone achievements
  • Develop full scale integrated project plans combining agile and waterfall methods to the respective needs
  • Responsible for tracking of project milestones, timelines and budget
  • Secures required resources and uses formal processes and tools to manage resources, budget, risks and changes
  • Carries out operational project controlling regarding time, quality and budget
  • Generate transparency of the projects ensuring routine reporting to respective governance bodies
  • Lead and co-ordination of multinational virtual project teams cross sites
  • Responsible for management of external stakeholder and aligning with project operational activities

YOUR QUALIFICATIONS

  • Degree/background in natural sciences (HTL, FH, University etc.)
  • Qualification in PM or proven track record in PM
  • Several years of work experience in project management, ideally in the life science environment
  • Detail-oriented and accurate working style
  • Very good communication and computer skills (i.e. Excel, MS Project, etc.)
  • Fluent English
  • Able to work in a team as well as independently
  • Able and used to work under time pressure on multiple projects in a fast changing environment

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

 

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 47.000,- 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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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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Technical Assistant Clinical Serology (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 needValneva 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

  • Setting up, validating, performing, analyzing and documenting assays for immunological monitoring of clinical trials according to GCLP
  • Participation in assay development and qualification/validation of GxP-compliant serological and cellular immune assays under BSL-2 and BSL-3 conditions
  • Performance of equipment qualifications, routine checks and maintenance work according to relevant GxP guidelines
  • Writing and reviewing of GxP relevant documentation in English language (SOPs, deviations etc.)

YOUR QUALIFICATIONS

  • MTA, BTA, DI (FH) or Master of Science in relevant field (Biology, Microbiology, Biotechnology, Bioengineering)
  • Experience working in a laboratory (preferably immunology, virology or biotechnology)
  • Working according to GxP within a recognized quality system is a plus
  • Accurate and reliable work style
  • Fluent in written and oral English
  • Good MS Office skills (Word and Excel)
  • Ability to work on multiple projects with challenging timelines

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

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 34.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Apply Now

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QC 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

  • Management of QC Analytics. Lead lab team (approx. 6 team members)
  • Implement and validate assays required for GMP release and stability testing according to relevant guidelines (e.g. ICH, FDA; EP, AMBO)
  • Supervise qualification/maintenance of equipment required for GMP release and stability testing according to relevant guidelines (e.g. ICH, FDA; EP; AMBO)
  • Planning and/or supervision of GMP testing including trouble shooting and data analysis.
  • Ensure efficient daily operations by coordinating resource allocations cross functions as needed.
  • Continues process improvements
  • Perform data review/approval/release required for release of raw materials, intermediate and final products
  • Maintain and ensure high quality of method performance
  • Create/review/approve Development Reports, Validation Protocols/Reports, SOPs & related documents
  • Issue, manage and close-out deviations, changes, investigations and CAPAs in a timely and independent manner

YOUR QUALIFICATIONS

Minimum requirements:

  • Completed master or PhD degree in Natural science studies (Biology, Chemistry, Biotechnology, etc.)
  • A minimum of four years GxP experience in the field of pharmaceutical production or quality control
  • Excellent analytical/problem solving skills
  • Excellent leadership, communication, organizational, documentation management and teamwork skills required
  • Good working knowledge of ICH/FDA/EMA/GMP and other applicable regulatory guidelines
  • Confident handling in MS Office
  • Very good German and good English skills
  • Accountability, decision making, ability to work in a team

Desirable requirements:

  • Computerized system validation

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 € 50.000 gross per year based on full-time employment.

However our salaries are market oriented and in line with your qualifications and experience.

Apply Now

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Valneva Locations

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

Austria

Vienna

VALNEVA Austria GmbH
Campus Vienna Biocenter 3
1030 Vienna, Austria
T: +43 1 20620 F: +43 1 20 620 800 Contact Us

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 Contact Us

France

Nantes

6 rue Alain Bombard
44800 SAINT-HERBLAIN
France
T: +33 228 07 37 10 F: +33 228 07 37 11 Contact Us

Lyon

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

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 Contact Us

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: +1 866 223 7118 Contact Us