At Valneva, we are proud of our past, present and future successes. Our achievements are based on our Company's culture, which is characterized by respect, dedication and motivation.

We are Valneva

“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.”

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, Senior Scientist in France

"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

"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

Valneva’s success stems from the dedication and expertise of over 600 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

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 600 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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Manufacturing Process Technician (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. The Company 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.

An opportunity has arisen in Livingston for Manufacturing Process Technicians.

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 Scientist (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. The Company 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.

An opportunity has arisen in Livingston for multiple Manufacturing Technicians. Initially working on a Mon – Fri dayshift, we will extend to become a 24/7 manufacturing operation in mid-2021.  We are asking your shift preferences so that we can discuss potential working patterns based on the various information provided.

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 essential
  • 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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Senior Technical Assistant – Quality Control (m/f/d), (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria
  • Required degrees: Bachelor/Master Degree or equivalent level in a relevant scientific field

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Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

YOUR RESPONSIBILITIES

  • Execution of diverse analytical procedures (e.g. ELISA, HPLC, UV VIS spectrophotometry, cell based assays, etc.) for testing of release and stability samples for marketed products according to defined standard operating procedures and protocols in compliance with the same
  • Perform routine cell culture
  • Execute lab activities for set up, transfer and validation of assays required for the release of raw materials, intermediate products and final products, including preparation/completion of protocols and reports
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Preparation and review of GMP relevant documentation (e.g. Deviations, Changes, SOPs)
  • Active participation in laboratory investigations and documentation thereof (e.g. in case of Deviations)
  • Assume responsibility for laboratory equipment including qualification thereof and oversight of regular cleaning, calibration and maintenance

YOUR QUALIFICATIONS

  • Bachelor/Master Degree or equivalent level in a relevant scientific field
  • Excellent technical lab skills (immunological assays, cell culture, chemical / biochemical / bioanalytical methods)
  • Experience in cell culture and GxP environment
  • Experience with equipment qualification and method validation is a plus
  • Excellent organizational, documentation management and teamwork skills
  • Proactive, accurate, reliable working style and problem solving skills
  • Ability to work on competing projects with limited resources
  • Team work and excellent organizational skills

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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(Senior) Technical Assistant – Clinical Trial Material Analytics (f/m/d) (Vienna, Austria)

  • Requisition ID: 11236-20-01-v
  • Position: Full time
  • Location: Vienna, Austria

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Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

Your Responsibilities

  • Setting up, transfer and validation of analytical GMP release and stability tests for multiple projects in the clinical development including preparation/completion of protocols and reports
  • Execution of diverse analytical procedures (e.g. ELISA, HPLC, cell based assays, etc.) as part of quality control testing of products / clinical trial materials according to defined standard operating procedures and protocols and in compliance with the same
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Preparation and review of GMP relevant documentation in English language (e.g. Deviations, Changes, SOPs)
  • Active participation in laboratory investigations and documentation thereof
  • Assume responsibility for laboratory equipment

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
  • Experience working with cell based methods, ELISA, SDS-Page and/or HPLC is a plus
  • Experience working with the qualification and validation of product
    testing methods is a plus
  • Excellent organizational, documentation management and teamwork
    skills
  • Proactive, accurate, reliable working style and problem solving skills
  • 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.

If you are interested in this challenging position, please apply by using the “Apply Now” button below.

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Research Assistant Preclinical Vaccine Development (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria
  • Required degrees: MTA, BTA, Dipl. Ing. (FH) or M.Sc. in a relevant field (e.g. immunology, microbiology, molecular biology)

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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

  • Perform and setup of serological assay such as ELISA, Flow cytometry, cell based functional assays and bactericidal assays and cell culture
  • Perform and setup of molecular biology experiments e.g. molecular cloning, PCR (qPCR, RT-qPCR) and sample preparation for sequencing
  • Plan experiments, evaluate and summarize data in reports
  • Maintenance of laboratory equipment
  • Train co-workers on internal methods, procedures and equipment use
  • Support the organization and the daily laboratory activities within the Pre-clinical Vaccine Development Department

YOUR QUALIFICATIONS

  • Preferably 1-2 years experience with molecular biology, immunological or virological techniques within life science industry
  • MTA, BTA, Dipl. Ing. (FH) or M.Sc. in a relevant field (e.g. immunology, microbiology, molecular biology)
  • Accurate with attention to details
  • Open-minded, communicative team player
  • Ability to work under time pressure on multiple projects in a changing environment
  • Proactive work style
  • Good English language skills
  • Eager to work with computers, data processing software and data bases
  • Used to work in international work 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 € 34.000,- 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) Logistique et Services Généraux (Nantes, France)

  • Position: Full time
  • Location: Nantes, France

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Company Highlights
Valneva est une société spécialisée dans le développement et la commercialisation de vaccins prophylactiques contre des maladies infectieuses générant d’importants besoins médicaux. Valneva a une approche hautement spécialisée et ciblée du développement de vaccins en identifiant des maladies infectieuses mortelles et débilitantes pour lesquelles il n’existe pas de solution vaccinale prophylactique et pour lesquelles les options thérapeutiques sont limitées. Valneva utilise ensuite sa forte connaissance de la science des vaccins, et notamment son expertise dans les différents modes de vaccination ainsi que ses infrastructures de développement de vaccins déjà bien établies, pour mettre au point des vaccins prophylactiques destinés à lutter contre ces maladies. 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, le virus du chikungunya et la COVID-19. Valneva compte environ 600 employés et exerce ses activités depuis l’Autriche, la Suède, la Grande-Bretagne, la France, le Canada et les Etats-Unis.

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

  • Assurer la réception des marchandises au quotidien :
    • Réception des marchandises livrées par les transporteurs incluant un contrôle visuel de l’état des colis.
    • Contrôle des marchandises réceptionnées : conformité des références livrées par apport aux commandes, respect des conditions de transport, intégrité des emballages.
    • Réception électronique des bons de livraison sous ERP (AX Dynamics).
  • Assurer la gestion des stocks et des références produits (sous ERP):
    • Gérer l’entrée en stock dans le magasin après réception.
    • Assurer la mise à jour quotidienne de l’état des stocks.
    • Créer les demandes d’achat nécessaires au maintien du stock.
    • Effectuer les sorties de stocks selon les procédures internes.
    • Créer les nouveaux articles non référencés.
  • Assurer les livraisons internes quotidiennes dans les laboratoires conformément aux bons de commande des opérateurs.
  • Assurer le suivi de prestataires externes : Gestion de l’arrivée et du départ des intervenants, accompagnement des prestataires dans le bâtiment et laboratoires.
  • Assurer le suivi de la prestation de bio-décontamination des laboratoires afin de suivre la bonne exécution des prestations demandées.
  • Assurer au quotidien les activités aux laboratoires :
    • Gestion des poubelles DASRI
    • Gestion de la laverie centrale
    • Gestion du rangement des sas et des laboratoires
    • Gestion des vêtements de travail de laboratoire (blouses et pyjamas)
  • Seconder le service de maintenance interne.
  • Réaliser des missions ponctuelles relatives au bon fonctionnement du bâtiment.

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

  • Vous maîtrisez la saisie de demandes d’achat, de bons de livraison sous un logiciel de gestion de stocks et commandes (ERP).
  • Vous êtes rigoureux(se) et disposez d’excellentes qualités d’organisation.
  • Vous avez le sens du service client.
  • Vous êtes réactif(ve) et faites preuve d’initiative.
  • Vous êtes familier(e) du respect des procédures et instructions de travail.
  • Maîtrise de l’anglais indispensable.

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Logistikkoordinator (Solna, Sweden)

  • Requisition ID: 201343214
  • Position: Full time
  • Location: Solna, Sweden

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Arbetsbeskrivning

Vi växer och söker nu därför en logistikkoordinator. Hos oss på Valneva får du en roll med mycket frihet och eget ansvar, och dessutom också vara med i arbetet med att stoppa covid19. Du ansvar över att se till att våra kunder får sina beställningar i tid så att deras verksamhet ska kunna flyta på så smidigt som möjligt.

Vi kan erbjuda dig varierande arbetsuppgifter och stora möjligheter att påverka och vara en del av vår utveckling.

Ansvarsområde

I rollen som vår logistikkoordinator hanterar du leveranser till våra kunder, med ansvar över planering, bokning, uppföljning samt att säkerställa att varor har levererats.
  •  Dokumentation i vårt ERP-system för både inkommande och utgående transporter.
  •  Initiera och driva förbättringsarbete inom ditt område, samt följa upp KPI:er.
  •  Stöttning av chefer och medarbetare i exportrelaterade frågor.
  •  Regelbunden kontakt med externa parter, transportörer, interna medarbetare samt 3PLS.
  •  Avvikelsehantering och problem som kan uppstå i leverans.
  •  Ansvar för att skapa kostnadseffektiva transporter.

Arbetstider

Heltid med arbetstid: Mån-fre kontorstider. Du blir anställd av Valneva.

Kvalifikationer

Rollen kräver att du har ett dedikerat kundfokus och att du kan hålla flera arbetsuppgifter igång parallellt. Du har ett proaktivt arbetssätt och ligger steget före för att förekomma eventuella problem och kommunicerar status för leverans på ett tydligt och trevligt sätt.

Vi ser också att du har:

  •  Minst 3 års liknande arbetserfarenhet.
  •  Erfarenhet av tull både import och export.
  •  Kunskap inom kylvaror och temperaturloggning.
Meriterande om du även har:
  •   Kunskaper inom regelverk för GDP
  •  Kunskaper inom Microsoft AX

Ansökan

2021-05-31, urval och intervjuer kommer att ske löpande. Tjänsten kan komma att bli tillsatt innan sista ansökningsdag, ansök därför så snart som möjligt.

För information: I den här tillsättningen samarbetar vi med Randstad där rekryteringskonsult Kristin Olofsson ansvarar för uppdraget och gärna svara på din frågor. https://Kristin.olofsson@randstad.se/

Om Valneva Sweden AB

Valneva har flera vacciner under utveckling, inklusive unika vacciner mot Borrelia, COVID-19 och chikungunya. Valnevas portfölj innehåller två kommersiella vacciner för resenärer: ett för förebyggande av japansk encefalit och ett för förebyggande av kolera. Valneva har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med över 500 anställda.

Valneva Sweden AB är den svenska delen av Valneva och har en lång historia. Bolaget bildades 1993 när dåvarande SBL, Statens Bakteriologiska Laboratorium, delades in i en myndighetsdel, Smittskyddsinstitutet (i dag en del av Folkhälsomyndigheten) och en bolagsdel, SBL Vaccin AB. Våren 2015 såldes vaccinbolaget av sin dåvarande ägare Crucell Sweden AB i Solna till det österrikisk-franska vaccinbolaget Valneva SE.

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Junior Pharmacovigilance Expert part-time (f/m/d) (Vienna, Austria)

  • Position: Part time
  • Location: Vienna, Austria
  • Required degrees: Degree (at least Master) in natural sciences (FH or University)

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YOUR RESPONSIBILITIES

  • Provide Quality Assurance support to operational Pharmacovigilance (PV) activities in order to ensure compliance with applicable regulatory requirements and Valneva’s procedures and quality standards
  • Support the maintenance of Valneva’s PV quality system focusing on document management and adequate filing/archiving
  • Perform routine PV activities
  • Support the preparation and review of all types of PV related documents and written procedures
  • Keep oversight of the PV document archiving system
  • Support initiatives with focus on quality, process and compliance improvement
  • Support the development, implementation and conduct of appropriate PV trainings
  • Support the maintenance of corrective and preventative action plans (CAPA)

YOUR QUALIFICATIONS

  • Degree (at least Master) in natural sciences (FH or University)
  • Experience in Pharmacovigilance is a plus
  • Knowledge of GxP relevant regulations is a plus
  • Excellent English and German skills
  • Good communication skills
  • Detail-oriented and accurate working style
  • High degree of commitment and strong sense of prioritization
  • Independent working style

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 € 35.000 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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Research Assistant Assay 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 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

  • Development of analytical methods, Set up, qualification and transfer of analytical tests for multiple projects of Valneva’s development pipeline including preparation/completion of protocols and reports
  • Execution of diverse analytical procedures (e.g. immunological and molecular biological methods, cell based assays, etc.) for supportive testing of clinical trial materials
  • Documentation including review and verification of analytical data according to established standards
  • Preparation and review of relevant documentation in English language (e.g. Development reports, Working instructions)
  • Active participation in laboratory investigations and documentation thereof
  • Assume responsibility for laboratory equipment

YOUR QUALIFICATIONS

  • MTA, BTA, DI (FH), Bachelor or Master of Science in relevant field (Biology, Microbiology, Biotechnology, Bioengineering)
  • Experience working in a laboratory (preferably immunology, virology or biotechnology)
  • Experience working with cell based methods, ELISA, SDS-Page, Western Blot is a plus
  • Excellent organizational, documentation management and teamwork skills
  • Experience working with qualification and validation of analytical methods is a plus
  • Proactive, accurate, reliable working style and problem solving skills
  • 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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Inventory 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 600 employees.

An opportunity has arisen within Valneva Scotland’s for an Inventory Manager to work within our Supply Chain Management Department in Livingston.

Job Summary

To ensure the receipt, storage and movement of all raw materials and finished bulk is executed in line with GMP and regulatory requirements to achieve key business objectives. To ensure a high level of compliance for the facility operations and maintain a high level of housekeeping.

Job Requirements

Experience: 

  • Relevant experience in warehousing & logistics, ideally in a regulated environment
  • Experience within a quality driven manufacturing environment
  • Awareness of health & safety principles
  • Developing and implementing SOPs and work instructions and other quality related documentation
  • Knowledge of working with ERP or relevant systems
  • Knowledge of process excellence techniques (5S/Lean/Six Sigma) is beneficial
  • Experience in data management including a working understanding of KPIs and metrics

Required Skills:

  • Ability to lead, motivate, inspire and develop teams
  • Excellent oral and written communication skills
  • Management skills and experience with proven track record on project and continuous improvement management
  • Ability to use initiative and be decisive working with tight deadlines
  • Problem solving skills and the ability to work on a tactical and strategic level
  • Display enthusiasm, flexibility and an innovative attitude

Job Responsibilities 

Warehouse Operations:

  • Organise and control the efficient and compliant receipt and storage of all raw materials, maintaining all systems and documentation.
  • Liaise with internal stakeholders to manage effective material flow according to stock levels and demand fluctuations
  • Support the definition of the inventory strategy through collaboration with Procurement team
  • Maintain a high level of housekeeping and organisation within all warehouse areas
  • Ensure all waste is stored and disposed of according to regulations, introducing efficiencies and cost savings where possible

Logistics:

  • Deliver against annual SCM budget and monitor monthly stats
  • Manage all Livingston transportation of Bulk material ensuring compliance
  • Assume responsibility for delivery of key transportation metrics
  • Liaise with stakeholders to ensure transportation requirements are fully met and filling operations are planned and executed effectively according to the MPS
  • Manage the compliant transportation of materials between all internal and external storage areas and facilities

General:

  • Provide day-to-day management of the department and contribute to an environment of energy, enthusiasm, empowerment and motivation. Implement teamwork practices to ensure the department is operating within GMP requirements at all times
  • Take accountability for the budget & performance of the Stores teams, adapting plans and priorities as required to address resource and operational challenges
  • Responsible for maintaining Quality Management, Compliance & GMP systems within own department and throughout the wider business
  • Manage the recruitment, training, continuous development, discipline and performance management of the Stores teams
  • Participate in a programme of continuous training and assessment to maintain and develop skills
  • Perform any other duties as reasonably requested from the Company from time to time
  • Provide administrative support for project meetings, generating minutes / trackers and following up on actions
  • Provide administrative support for site audit and inspections

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Medical Information Expert (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

  • Represent Valneva medical/scientific voice of expertise for assigned products and relevant therapeutic areas
  • Provide medical information to Valneva partners & customers in accordance with current legislation directly & in second line
  • Oversee internal & external medical information flow, including documentation and tracking
  • Oversee agreed medical information services with distribution partners & service providers
  • Set-up & update of Frequently Asked Questions
  • Quarterly Statistical Medical Information data processing
  • Product training for internal & external partners
  • Support for Audits & Inspections

Your Qualifications

  • Degree (at least Master) in natural sciences (FH or University)
  • Experience in Medical Information is a plus
  • Knowledge of GxP relevant regulations is a plus
  • Excellent English and German skills
  • Good French skills is a plus
  • Detail-oriented and accurate working style
  • High degree of commitment and strong sense of urgency
  • Independent working style

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 € 35.000,- 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 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

  • 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 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.

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Training Specialist (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 600 employees.

An opportunity has arisen at Valneva Scotland for a Training Specialist within the HR Team.

Job Summary

Experienced Training Specialist  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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Comptable Fournisseurs (Nantes, France)

  • Position: Full time
  • Location: Nantes, 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. Valneva a une approche hautement spécialisée et ciblée du développement de vaccins en identifiant des maladies infectieuses mortelles et débilitantes pour lesquelles il n’existe pas de solution vaccinale prophylactique et pour lesquelles les options thérapeutiques sont limitées. Valneva utilise ensuite sa forte connaissance de la science des vaccins, et notamment son expertise dans les différents modes de vaccination ainsi que ses infrastructures de développement de vaccins déjà bien établies, pour mettre au point des vaccins prophylactiques destinés à lutter contre ces maladies. 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, le virus du chikungunya et la COVID-19. Valneva compte environ 600 employés et exerce ses activités depuis l’Autriche, la Suède, la Grande-Bretagne, la France, le Canada et les Etats-Unis.

Missions
Nous recherchons un Comptable Fournisseurs H/F en CDI pour renforcer notre équipe basée à Saint-Herblain (Nantes). Sous la direction du Responsable comptable France, le Comptable Fournisseurs H/F prendra en charge le traitement des factures fournisseurs et notes de frais de deux sociétés.

  • Numérisation et comptabilisation des factures via un ERP (Microsoft Dynamics AX 2012) et un outil de dématérialisation et de validation des factures: Rapprochement des factures avec les commandes, suivi de la validation des factures par les responsables des centres de coûts.
  • Comptabilisation des notes de frais.
  • Préparation des fichiers de règlement conformément aux échéances.
  • Justifications des comptes fournisseurs dans le cadre des clôtures mensuelles (J+3), trimestrielles et annuelles. Dans le respect des procédures de contrôle interne SOX et les principes comptables FGAAP.

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

Profil
De formation Bac+2 en comptabilité, vous justifiez d’une expérience de 1 an ou plus sur un poste similaire, acquise de préférence au sein d’une entreprise internationale.

Vous faites preuve de rigueur, êtes doté(e) d’un très bon relationnel et avez le sens des responsabilités. Vous savez organiser votre travail de manière autonome et en tenant des délais courts.

Vous êtes capable d’échanger en anglais avec des correspondants internes et externes.

Vous maîtrisez un ERP (Microsoft Dynamics AX 2012 serait un plus) et Excel

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Technicien(ne) Recherche et développement Préclinique (Nantes, France)

  • Position: Full time
  • Location: Nantes, 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. Valneva a une approche hautement spécialisée et ciblée du développement de vaccins en identifiant des maladies infectieuses mortelles et débilitantes pour lesquelles il n’existe pas de solution vaccinale prophylactique et pour lesquelles les options thérapeutiques sont limitées. Valneva utilise ensuite sa forte connaissance de la science des vaccins, et notamment son expertise dans les différents modes de vaccination ainsi que ses infrastructures de développement de vaccins déjà bien établies, pour mettre au point des vaccins prophylactiques destinés à lutter contre ces maladies. 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, le virus du chikungunya et la COVID-19. Valneva compte environ 600 employés et exerce ses activités depuis l’Autriche, la Suède, la Grande-Bretagne, la France, le Canada et les Etats-Unis.

Key Responsibilities

Nous cherchons 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 :

  • Mise en place et application de procédés de production des candidats vaccinaux en cours de développement.
  • Mise en pratique des techniques telles que la culture cellulaire de mammifères, la transfection/l’infection de cellules eucaryotes et des méthodes analytiques couramment utilisés en virologie (SDS-PAGE, quantification par méthode biochimique, ELISA, test pour déterminer le titre viral).
  • Organisation et réalisation des expériences définies par le manager et les ingénieurs de l’équipe.
  • Proposition et réalisation de protocoles lors de la mise en place de nouvelles techniques ou en vue d’optimiser les techniques de routine.
  • 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.
  • Assurer la gestion des stocks de matériels et réactifs propres aux expériences en collaboration avec l’équipe Logistique.
  • Participation active à la vie de l’équipe.

Profile

  • Licence bio-industries, biotechnologies, ESTBA, ou autre formation avec dominante de culture cellulaire et développement de procédés de production.
  • Cinq années minimum d’expérience dans une entreprise de biotechnologie ou pharmaceutique.
  • Qualifié(e) dans le domaine de la biologie cellulaire et techniques biochimiques (compétences en virologie et biologie moléculaire sont 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.
  • Esprit d’équipe, flexible, curieux(se), attiré(e) par la découverte et les nouveaux défis

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Anläggningsingenjör (Solna, Sweden)

  • Position: Full time
  • Location: Solna, Sweden

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Söker du ett mångsidigt och varierande jobb där du kan utvecklas inom flera teknikområden tillsammans med erfarna kollegor? Då kan tjänsten som anläggningsingenjör på Valneva vara din nästa utmaning.

Dina arbetsuppgifter i huvudsak

Som anläggningsingenjör ansvarar du och dina kollegor för samtliga tekniska system på anläggningen i Solna. Detta inkluderar övervakning, underhåll, service, kvalificeringar, valideringar och kalibreringar, och omfattar exempelvis system för sterilvattenproduktion, produktion av renånga, HVAC, autoklaver och kylanläggningar. Den stora variationen i utrustning på anläggningen i Solna medför att tjänsten både är teknisk utmanande och omväxlande.
Engineering ansvar också för fastighetsdriften med ovanstående områden på c:a 14 000m2 .
I tjänsten ingår beredskapstjänstgöring var 6:e vecka.

Vem är du?

  • Ingenjörsutbildning eller motsvarande erfarenhet inom relevant arbetsområde
  • Erfarenhet av dokumentation, processutförande samt rapportdokumentation
  • Erfarenhet av att koordinera utrustning och anläggningens underhåll och kalibreringsprogram
  • Erfarenhet av att hantera arbetsmiljö, hälsa- och säkerhetsfrågor samt arbetstillstånd (så som säkra stop, heta arbeten) är meriterande

Du är en händig och mångsidig tekniker/ingenjör med erfarenhet av underhåll och installation. Kunskap inom autoklav, steriliseringsutrustning är meriterande. Du har erfarenhet av underhåll för media så som WFI- anläggning (Water For Injection), värme/kylsystem och ventilation. Även styr- och reglerteknik samt automation såsom IFIX och SCADA är en fördel. Du behärskar svenska och engelska i tal och skrift. Du har kunskap i Microsoft Word och Excel. Körkort är ett krav.
För denna roll söker vi en prestigelös lagspelare som gillar att lösa problem och som är serviceinriktad.

Om verksamheten

Valneva har flera vacciner under utveckling, inklusive unika vacciner mot Borrelia, COVID-19 och chikungunya. Valnevas portfölj innehåller två kommersiella vacciner för resenärer: ett för förebyggande av japansk encefalit och ett för förebyggande av kolera. Valneva har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med över 600
anställda.

Valneva Sweden AB är den svenska delen av Valneva och har en lång historia. Bolaget bildades 1993 när dåvarande SBL, Statens Bakteriologiska Laboratorium, delades in i en myndighetsdel, Smittskyddsinstitutet (i dag en del av Folkhälsomyndigheten) och en bolagsdel, SBL Vaccin AB. Våren 2015 såldes vaccinbolaget av sin dåvarande ägare Crucell Sweden AB i Solna till det österrikisk-franska vaccinbolaget Valneva SE.

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Anläggningsingenjör med elbehörighet (Solna, Sweden)

  • Position: Full time
  • Location: Solna, Sweden

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Söker du ett mångsidigt och varierande jobb där du kan utvecklas inom flera teknikområden tillsammans med erfarna kollegor? Då kan tjänsten som anläggningsingenjör på Valneva vara din nästa utmaning.

Dina arbetsuppgifter i huvudsak

Som anläggningsingenjör ansvarar du och dina kollegor för samtliga tekniska system på anläggningningar i Solna. Detta inkluderar övervakning, underhåll, service, kvalificeringar, valideringar och kalibreringar, och omfattar exempelvis system för sterilvattenproduktion, produktion av renånga, HVAC, autoklaver och kylanläggningar. Den stora variationen i utrustning på anläggningen i Solna medför att tjänsten både är teknisk utmanande och omväxlande.
Engineering ansvar också för fastighetsdriften med ovanstående områden på c:a 14 000m2 .
I tjänsten ingår beredskapstjänstgöring var 6:e vecka.

Vem är du?

  • El-teknisk utbildning med elbehörighet
  • Erfarenhet av dokumentation, processutförande samt rapportdokumentation
  • Erfarenhet av att koordinera utrustning och anläggningens underhåll och kalibreringsprogram
  • Erfarenhet av att hantera arbetsmiljö, hälsa- och säkerhetsfrågor samt arbetstillstånd (så som säkra stop, heta arbeten) är meriterande

Du är en händig och mångsidig tekniker/ingenjör med erfarenhet av underhåll och installation. Kunskap inom autoklav, steriliseringsutrustning är meriterande. Du har erfarenhet av underhåll för media så som WFI- anläggning (Water For Injection), värme/kylsystem och ventilation. Även styr- och reglerteknik är en fördel såsom IFIX och SCADA . Du behärskar svenska och engelska i tal och skrift. Du har kunskap i Microsoft Word och Excel. Körkort är ett krav. Vi fäster stor vikt på personlig lämplighet

För denna roll söker vi en prestigelös lagspelare som gillar att lösa problem och som är serviceinriktad.

Om verksamheten

Valneva har flera vacciner under utveckling, inklusive unika vacciner mot Borrelia, COVID-19 och chikungunya. Valnevas portfölj innehåller två kommersiella vacciner för resenärer: ett för förebyggande av japansk encefalit och ett för förebyggande av kolera. Valneva har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med över 600
anställda.

Valneva Sweden AB är den svenska delen av Valneva och har en lång historia. Bolaget bildades 1993 när dåvarande SBL, Statens Bakteriologiska Laboratorium, delades in i en myndighetsdel, Smittskyddsinstitutet (i dag en del av Folkhälsomyndigheten) och en bolagsdel, SBL Vaccin AB. Våren 2015 såldes vaccinbolaget av sin dåvarande ägare Crucell Sweden AB i Solna till det österrikisk-franska vaccinbolaget Valneva SE.

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Procurement Assistant (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 600 employees.

An opportunity has arisen at Valneva Scotland for a Procurement Administrator within our SCM Procurement Department, working on a 12 month Fixed Term Contract.

Job Summary

The Procurement Administrator 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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QC Coordinator (Raw Materials) (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 600 employees.

A full-time opportunity has arisen at Valneva Scotland for a QC Coordinator (Raw Materials)

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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Stores 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 600 employees.

Due to the increase in business we are currently recruiting for a Stores Person to work at our Livingston site.

Job Summary

To support all Supply Chain activities including receipt of all raw materials and consumables, stock control and transferring materials between Valneva sites. Adhering to Valneva policies, ensure raw material stocks are available in the right locations at all times.

Responsibilities

  • Receipt and quarantine of supplies
  • Identify and take responsibility for achieving personal training standards required
  • Take personal responsibility for the safe operation within the Warehousing
  • Awareness of the relevant modules of Valneva’s electronic supply management system
  • Support in the implementing of systems, policies and procedures for effective running of the stores, taking into account any relevant regulatory requirements.
  • Receiving deliveries and ensuring that the material conforms to that specified on the purchase order and internal specifications
  • Inform QC of materials that require release approval and move all deliveries to the appropriate areas
  • Operate first in first out (FIFO) policy and first expired (FEFO) for raw materials and consumables
  • Replenish the stock via the inventory management process, ensuring stock is available on time
  • Clear stores of any un-used and expired material as per standard operating procedures
  • Maintain high standards of housekeeping in the warehousing areas
  • You will be required to travel between Valneva Scotland sites
  • You will be required to drive company vehicles including transferring materials between sites
  • You will be required to work different shift patterns between Day shift/Back shift and continental shifts as determined by the business needs.
  • Removal of the waste generated by Goods In
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • You will also be responsible for your own QMS

Job Requirements

  • Stores experience preferably within a structured (GMP/GLP) environment
  • Current driving licence pre January 1997 to allow driving of company vehicle
  • Forklift, Counter Balance and Reach Truck Experienced preferred

Required Skills

  • Strong attention to detail
  • Good communication skills

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Stores Person (12 month FTC) (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 600 employees.

Due to the increase in business we are currently recruiting for a Stores Person to work on a 12 month fixed term contract to work at our Livingston site.

Job Summary

To support all Supply Chain activities including receipt of all raw materials and consumables, stock control and transferring materials between Valneva sites. Adhering to Valneva policies, ensure raw material stocks are available in the right locations at all times.

Responsibilities

  • Receipt and quarantine of supplies
  • Identify and take responsibility for achieving personal training standards required
  • Take personal responsibility for the safe operation within the Warehousing
  • Awareness of the relevant modules of Valneva’s electronic supply management system
  • Support in the implementing of systems, policies and procedures for effective running of the stores, taking into account any relevant regulatory requirements.
  • Receiving deliveries and ensuring that the material conforms to that specified on the purchase order and internal specifications
  • Inform QC of materials that require release approval and move all deliveries to the appropriate areas
  • Operate first in first out (FIFO) policy and first expired (FEFO) for raw materials and consumables
  • Replenish the stock via the inventory management process, ensuring stock is available on time
  • Clear stores of any un-used and expired material as per standard operating procedures
  • Maintain high standards of housekeeping in the warehousing areas
  • You will be required to travel between Valneva Scotland sites
  • You will be required to drive company vehicles including transferring materials between sites
  • You will be required to work different shift patterns between Day shift/Back shift and continental shifts as determined by the business needs.
  • Removal of the waste generated by Goods In
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • You will also be responsible for your own QMS

Job Requirements

  • Stores experience preferably within a structured (GMP/GLP) environment
  • Current driving licence pre January 1997 to allow driving of company vehicle
  • Forklift, Counter Balance and Reach Truck Experienced preferred

Required Skills

  • Strong attention to detail
  • Good communication skills

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Responsable Médical / Medical Advisor (Lyon, France)

  • Requisition ID: FR-MAFFAD
  • Position: Full time
  • Location: Lyon, France

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Valneva est une société spécialisée dans les vaccins contre les maladies générant d’importants besoins médicaux. Le Groupe possède un solide portefeuille de vaccins en développement dont des candidats vaccins uniques contre la maladie de Lyme, la COVID-19 et le chikungunya. Le Groupe commercialise par ailleurs deux vaccins de voyageur. Valneva compte environ 600 employés et exerce ses activités depuis l’Autriche, la Suède, la Grande-Bretagne, la France, le Canada et les Etats-Unis.

Job Description
Le portefeuille de Valneva est constitué de vaccins du voyageur. Parmi les produits en développement avancé, le vaccin contre le Chikunguya, attendu pour une mise sur le marché en 2023, est actuellement le seul produit en phase III contre cette maladie. Il a reçu la désignation Fast Track de la FDA et la désignation PRIME de l’Agence européenne des médicaments.

Afin d’assurer le lancement de nos produits , Valneva SE crée le poste de Responsable Médical Europe. Rattaché au VP global Medical Affairs, en collaboration avec l’équipe globale marketing basée à Lyon et avec l’équipe Affaires Médicales répartie en Europe et Amérique du Nord.

Key Responsibilities
Vous aurez pour principales missions de :

  • Développer et exécuter les stratégies médicales de lancement
  • Animer les interactions avec les experts scientifiques en Europe afin de les associer au développement des produits
  • Diffuser un contenu scientifique à forte valeur ajoutée pour les activités d’éducation médicale, assurant ainsi une amélioration de la connaissance, de la pratique médicale et un accès équitable à la vaccination contre ces maladies
  • Assurer la formation médicale des membres de l’équipe.

Profile
De formation scientifique, (MD, Pharm D, formation supérieures Sciences de la Vie ), vous bénéficiez d’au moins 5 ans d’expérience en affaires médicales pharma ou biotech incluant un lancement de produit dans le domaine du vaccin ou des maladies infectieuses. Vos qualités de présentation et de communication scientifiques sont reconnues. Une expérience de recherche clinique et de gestion d’essais sera une réelle valeur ajoutée.

Vous souhaitez mettre votre expertise scientifique et votre capacité d’innovation au profit du développement d’un nouvel acteur du monde du vaccin et contribuer ainsi à une aventure à taille humaine où votre impact sera tangible. Vous aimez avoir l’espace permettant de faire preuve d’autonomie, d’agilité et de pragmatisme et êtes orienté sur le résultat , tout en étant familier de l’environnement matriciel.

Votre excellent relationnel et capacité à convaincre vous permettent non seulement d’être reconnu comme joueur d’équipe mais aussi de contribuer activement au positionnement et au rayonnement de votre entreprise auprès des acteurs scientifiques du vaccin en Europe.

La pratique d’un anglais courant est indispensable. Poste basé à Lyon.

Contract
Permanent contract, full-time position based in Lyon, France.

Travel is national and International.

Contact
arnaud.corlosquet@valneva.com – Reference FR-MAFFAD

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Regulatory Affairs 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

  • 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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Project Coordinator (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 600 employees.

An opportunity has arisen within Valneva Scotland’s for a Project Co-ordinator to join the team on a 12 month FTC.

Job Requirements

Experience:

  • Experienced in managing / delivering projects.
  • Ideally experienced working within a pharmaceutical environment, understanding and using GMP processes.
  • Proficient in the use of Microsoft systems; MS project, Excel, Word & PowerPoint.
  • An effective team player who is able to establish and build strong business relationships
  • Communicate to all levels of the business/share holders
  • Ability to manage conflicting priorities, workloads and capable of influencing team members to achieve required project goals and milestones
  • Proactive while being able to work to own initiative

Responsibilities 

  • Provide project management support and drive for projects as determined and assigned by the Head of Operational Planning
  • Support project managers to create and deliver project plans, revise as appropriate to meet changing needs and requirements in alignment and agreement with the project sponsor and Head of Operational Planning
  • Set up and manage regular project team meetings with internal and external team members
  • Generate and distribute meeting minutes to the team and relevant stakeholders
  • Using the appropriate project management tools maintain and track project performance
  • Identify and manage project risks by escalating issues to the project team, sponsor and Head of Operational Planning
  • Manage all project activities in accordance and consideration of GMP requirements
  • Maintain project related documentation; ensuring project documents are complete, current, and stored appropriately
  • Support the review of completed projects, ensuring that learning points are captured and actioned in order to drive continual improvement
  • Provide administrative support for project meetings, generating minutes / trackers and following up on actions
  • Provide administrative support for site audit and inspections

Required Skills:

  • Excellent planning and organisational skills
  • Excellent interpersonal skills, ability to influence and motivate at all levels
  • Possess excellent communication skills both verbal and written
  • Multitasking / Prioritisation
  • Time management
  • Meeting management
  • Active listener
  • Positive thinker
  • Possess good IT skills

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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 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.

100% as soon as possible (limited for 1 year)

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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Senior Scientist Pre-clinical R&D (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria

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YOUR RESPONSIBILITIES

  • Planning, analysis, review and troubleshooting of external pre-clinical animal models
  • Writing and reviewing of technical protocols / reports for external studies
  • Co-ordinate and liaise with external parties regarding pre-clinical animal models and other studies
  • Verification and review of set-up for immunological assays used for assessing pre-clinical vaccine candidates
  • Active participation at various vaccine programs or projects focusing on pre-clinical activities
  • Contribution to selection of new vaccine candidates for pre-clinical and clinical development
  • Build and maintain scientific expertise for dedicated vaccine indication
  • Become an integral part of highly interactive team working on multiple projects
  • Preparation and review of scientific manuscripts for publication

YOUR QUALIFICATIONS

  • PhD in relevant scientific field (preferred: immunology)
  • Several years of work experience in the life science environment
  • Background in vaccinology and animal models
  • Willingness to work in a research as well as GxP-regulated environment
  • Ability to work according to challenging timelines
  • Team work, excellent organizational skills
  • Excellent analytical/problem solving skills
  • 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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Lagermedarbetare / Export assistent till vaccinföretaget (Solna, Sweden)

  • Requisition ID: Vl0321
  • Position: Full time
  • Location: Solna, Sweden

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Academic Resource söker två lagermedarbetare till vaccinföretaget Valneva. I arbetet ingår hantering och lagring av inkommande och utgående råvaror inklusive kemisk råvara. Du kommer vara en del av en serviceorganisation och tillsammans med andra gruppmedlemmar säkerställa en smidig daglig drift av godshantering. Tjänsten är på heltid och arbetstiderna är till en början dagtid och eventuellt skiftarbete kan förekomma. Du kommer att bli anställd av Valneva och arbeta i Solna, inklusive den nya anläggningen i Tomteboda. Vill du vara med på en spännande och utvecklande resa där Valneva satsar på Covidvaccin? Sök rollerna och var med och bidra till framtidens vaccinutveckling!
Vi söker dig som kan börja i maj.

På avdelningen för Warehouse & Distribution hanteras inkommande och utgående råvaror inklusive kemisk råvara. Här arbetar totalt 6 personer med lagerhantering, kundtjänst, supply chain- och GMP-frågor. Du kommer att rapportera till chef för Warehouse & Distribution. Vi söker dig som är van att arbeta i en serviceposition med både interna och externa kunder där du snabbt kan anpassa dig till en dynamisk miljö.

Valneva har flera vacciner under utveckling, inklusive unika vacciner mot Borrelia, COVID-19 och chikungunya. Valnevas portfölj innehåller två kommersiella vacciner för resenärer: ett för förebyggande av japansk encefalit och ett för förebyggande av kolera. Valneva har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med över 500 anställda.

Om Valneva
Valneva Sweden AB är den svenska delen av Valneva och har en lång historia. Bolaget bildades 1993 när dåvarande SBL, Statens Bakteriologiska Laboratorium delades in i en myndighetsdel, Smittskyddsinstitutet (i dag en del av Folkhälsomyndigheten) och en bolagsdel, SBL Vaccin AB. Våren 2015 såldes vaccinbolaget av sin dåvarande ägare Crucell Sweden AB i Solna till det österrikisk-franska vaccinbolaget Valneva SE.”
Mer information hittar du på www.valneva.com.

Arbetsuppgifter
•Säkerhetsställa en smidig drift av lagring av råvaror samt kemisk råvara
•Märkning av inkommande råvaror samt transport av råvaror och vaccin på anläggningen
•Förbereda mottagnings- och fraktdokument enligt instruktioner
•Registrera inkommande varor, lagerflyttar, uttag av material, etc. i Microsoft AX, Valnevas ERP-system
•Uppvägning av råvaror i renhetshetsklassad miljö (D) inför produktion
•Arbeta enligt GMP/GDP och SOP:ar

Arbetsuppgifte
•Minst tre års erfarenhet av lagerarbete i GMP reglerad industri/miljö
•Erfarenhet av lagerarbete med högt värderade varor
•Erfarenhet av arbete i läkemedelsbranschen eller liknande GMP miljö
•Arbetat med gaffeltruck/pallastare
•Arbetat med ERP-system Microsoft AX
•Flytande i svenska i tal och skrift

Din profil
I den här rollen ser vi en driven och serviceminded person som trivs med att ta eget ansvar och självständigt utföra sitt arbete. Du är noggrann och arbetar på ett strukturerat sätt men samtidigt flexibel för omprioriteringar och resultatinriktad. Det är bra om du har god förmåga att sätta dig in i olika mjukvaror/datasystem. Egenskaper som värderas högt är god samarbetsförmåga och en positiv attityd som bidrar till ett bra arbetsklimat. Är du den vi söker?

Ansökan
Intervjuer och urval kommer att ske löpande, så skicka gärna din ansökan så snart som möjligt. Klicka nedan på sök tjänsten och fyll i dina kontaktuppgifter, ange referensnamn: Vl0321

Frågor besvaras via mail av:
rekrytering.lifescience@academicresource.se

Sökord: Valneva lager warehouse gdp gmp kvalitet kontroll produktion vaccin administration dokumentation läkemedel industri process rekrytering solna lediga jobb stockholm mottagning frakt export import supply chain transport kundtjänst

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Synare / Processoperatörer till vaccinföretaget (Solna, Sweden)

  • Requisition ID: Vps0221
  • Position: Full time
  • Location: Solna, Sweden

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Academic Resource söker Synare och processoperatörer för inspektion och packning av Covid19-vaccin till företaget Valneva i Solna, Stockholm. Tjänsten är konsultuppdrag på heltid och vi söker kandidater som kan arbeta under perioden juni– oktober, juni-november och/eller juni-december. Tjänsten är ett konsultuppdrag enligt överenskommelse.

Som synare kommer du att tillhöra avdelningen tillverkning/slutprodukt och dina huvudsakliga arbetsuppgifter kommer att innefatta självständigt arbete med visuell syning och inspektion av vacciner. Vidare så kommer du att tränas och utbildas på plats inom området i samband med uppdragets start.

Arbetsuppgifter
•Manuell syning av flaskor
•Dokumentera och registrera avvikelser
•Följa gällande GMP regler, tillverkningsmetoder och instruktioner
•Bidra till att verksamheten uppfyller GMP-kraven

Kvalifikationer
Vi söker dig som:
•Har arbetat som synare tidigare och/eller har liknande erfarenhet av arbete inom läkemedelsindustrin eller processindustrin
•Har god syn med eller utan glasögon
•Har erfarenhet av GMP är meriterande
•Talar och skriver svenska flytande är ett krav

Vi ser i den här rollen en strukturerad och noggrann person som har god förmåga att hålla fokus och se detaljer. Arbetet är monotont och vi söker därför dig som gillar att arbeta enligt fasta rutiner. Vidare är du en ansvarsfull och engagerad person som gillar att arbeta målinriktat. Vi ser även att du har lätt att samarbeta och är en teamplayer beroende på gruppens och företagets behov.

Om Valneva
Valneva har flera vacciner under utveckling, inklusive unika vacciner mot Borrelia, COVID-19 och chikungunya. Valnevas portfölj innehåller två kommersiella vacciner för resenärer: ett för förebyggande av japansk encefalit och ett för förebyggande av kolera. Valneva har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med över 500
anställda.

Valneva Sweden AB är den svenska delen av Valneva och har en lång historia. Bolaget bildades 1993 när dåvarande SBL, Statens Bakteriologiska Laboratorium, delades in i en myndighetsdel, Smittskyddsinstitutet (i dag en del av Folkhälsomyndigheten) och en bolagsdel, SBL Vaccin AB. Våren 2015 såldes vaccinbolaget av sin dåvarande ägare Crucell Sweden AB i Solna till det österrikisk-franska vaccinbolaget Valneva SE.”
Mer information hittar du på www.valneva.com.

Är du den vi söker?

Ansökan
Intervjuer och urval kommer att ske löpande, så skicka gärna din ansökan så snart som möjligt. Klicka nedan på “Sök tjänsten genom att klicka här” och fyll i dina kontaktuppgifter, ange referensnamn: Vps0221

Kontaktperson för tjänsten: Carin Helander
rekrytering@academicresource.se
Observera att vi tar ej tar emot ansökningar via mail/e-post.

Sökord: synare, packare, gmp, läkemedelsföretag, läkemedel, vaccin, process, operatör, förpacka, lager, Stockholm, linjerensning, dokumentation, processindustrin

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Processoperatör packning till vaccinföretaget (Solna, Sweden)

  • Requisition ID: Vpp0221
  • Position: Full time
  • Location: Solna, Sweden

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Academic Resource söker flera processoperatörer till packning av Covid 19-vaccin till vaccinföretaget Valneva i Solna. Tjänsten är konsultuppdrag på heltid och vi söker kandidater som kan arbeta perioden mars-december, juni – december och augusti – december med goda möjligheter till förlängning.

Valneva har flera vacciner under utveckling, inklusive unika vacciner mot Borrelia, COVID-19 och chikungunya. Valnevas portfölj innehåller två kommersiella vacciner för resenärer: ett för förebyggande av japansk encefalit och ett för förebyggande av kolera. Valneva har verksamhet i Österrike, Sverige, Storbritannien, Frankrike, Kanada och USA med över 500
anställda.

Om Valneva
Valneva Sweden AB är den svenska delen av Valneva och har en lång historia. Bolaget bildades 1993 när dåvarande SBL, Statens Bakteriologiska Laboratorium, delades in i en myndighetsdel, Smittskyddsinstitutet (i dag en del av Folkhälsomyndigheten) och en bolagsdel, SBL Vaccin AB. Våren 2015 såldes vaccinbolaget av sin dåvarande ägare Crucell Sweden AB i Solna till det österrikisk-franska vaccinbolaget Valneva SE.”
Mer information hittar du på www.valneva.com.

Avdelningen som man kommer tillhöra arbetar med visuell inspektion och förpackning av vaccin. Som Processoperatör kommer du att packa vaccinet både manuellt och med hjälp av maskin. Du kommer att arbeta självständigt med förpackning av vaccinet både manuellt och automatiskt.

Arbetsuppgifter:
• Förpacka vaccin, även manuell packning
• Utföra dokumentation inklusive utbytesberäkningar
• Utföra och dokumentera provtagning
• Linjerensning enligt certifiering
• Rigga och tekniskt sköta förpackningsmaskinen
• Utföra och dokumentera formatbyten
• Lagerhantering

Kvalifikationer
Vi söker dig som har erfarenhet av liknande arbete inom processindustrin. Tidigare erfarenhet av GMP är meriterande och att du arbetat med förpackning. Vi ser gärna att du arbetat med dokumenthantering inom läkemedelsindustrin.

Som person
Vi söker dig som har lätt att samarbeta och är en teamplayer beroende på gruppens och företagets behov. Arbetet är monotont och omfattar även tunga lyft stundtals, vi söker dig som gillar att arbeta enligt rutiner. Vidare är du en ansvarsfull och engagerad person som gillar att arbeta målinriktat. Vi söker dig som är ambitiös och flexibel.

Är du den vi söker?

Ansökan
Intervjuer och urval kommer att ske löpande, så skicka in din ansökan så snart som möjligt. Klicka nedan på sök tjänsten och fyll i dina kontaktuppgifter, ange referensnamn: Vpp0221

Kontaktperson för tjänsten: Carin Helander
rekrytering@academicresource.se
Observera att vi tar ej tar emot ansökningar via mail/e-post.

Sökord: processoperatör valneva packare gmp läkemedel vaccin förpacka lager formatbyten Stockholm linjerensning dagtid dokumentation lager industri konsult

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QA Specialist (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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These are exciting times at Valneva!  As we continue to expand our business in Livingston, we are looking for a number of experienced QA Specialists.

The Role:

You will be assisting in developing and maintaining a comprehensive quality management system to achieve inspection readiness for Japanese Encephalitis Virus Vaccine (JEV), Coronavirus Vaccine (SARS-CoV-2) and other new products as required.  Additionally, you will act as Quality Assurance support for Valneva’s distribution network.

Your responsibilities will include:

  • Developing, monitoring, improving and maintaining procedures to ensure compliance with EU/FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals.
  • Performing activities and reviews in accordance with relevant Standard Operating Procedures, including but not limited to:
    • Risk assessments
    • Externally prepared documents
    • CAPA
    • Change requests
    • Deviations (including Quality Investigations, EME’s and OOS)
    • Complaints (customer / supplier)
    • Development Studies / Reports
    • QMS data logs
    • Room release documentation
    • Batch record review (including PPRs, PTRs, MPRs and SPRs)
    • Fill / Finish documentation
    • Product defect reporting and Quality Investigations
    • Technical and Quality Agreements
    • Validation
  • Performing batch review duties in accordance with relevant procedures, including issuing Certificates of Non-Conformance for bulk drug product and review of QC batch test folders
  • Identifying, investigating and reporting quality issues, escalating to management as required
  • 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, cGMP requirements and QA concepts
  • Trend and report batch reviews and QMS data
  • 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
  • Previous QA experience
  • 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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HR Manager (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and Chikungunya. Valneva’s portfolio also includes two commercial vaccines for travellers.  Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees.

An opportunity has arisen at Valneva Scotland for an HR Manager.

Job Summary

Lead and manage HR team to ensure all HR systems and processes for the Company are being developed and executed in a compliant manner.  Provide full strategic HR support to the site executive team, ensuring an approachable and professional HR service to all, which offers effective solutions for business needs. Advising and coaching Line Managers, Function Heads and other customers in the efficient and consistent application of HR policies and procedures which reflect business needs and current legislation including advising of any updates. Maintaining a mind-set, which promotes positive values and behaviours in all interactions throughout the site.

Responsibilities

  • Represent and facilitate a professional, knowledgeable and current HR service to the site, encouraging the team contribution to ensure consistent service levels
  • Lead all recruitment, deployment and HR contractual change processes
  • Be responsible for the development, collating and reporting of key quality and business metrics related to HR and use such metrics to drive a culture of continuous process improvement.
  • Manage and oversee the effective and qualitative data from HRM system
  • Implementation of HR aspects of any major change program in accordance with agreed timescales, deliverables etc. established for the program in question
  • Actively contribute to the development of an enthusiastic, supportive and collaborative environment across the site
  • Advice to senior managers on appointments, remuneration, development, performance management, etc.
  • Provide general day to day HR support on operational issues, with best-fits needs approach for the business
  • Management of maternity / paternity and flexible working arrangements in line with legislation and company policy
  • Developing and maintaining effective ER relationships with all staff
  • Continually seek to challenge and make recommendations to the HR Director on new HR initiatives which are cost effective and support business activities
  • Responsible for managing the annual performance management process including sign off for all G&Os across the site
  • Attend and contribute to corporate HR workshops involved in the integration, harmonisation and implementation of new or updated policies and processes for business needs
  • Immediately escalate any material breach to employment law or internal HR policies to MD
  • To undertake any other duties as requested by the HR Director and HSE in accordance with company requirements

Experience

  • Educated to degree level / equivalent experience in HR
  • Good understanding of business and strategy development processes
  • Successful track record of relationship management
  • Well rounded HR professional
  • Working with senior teams on complex change
  • Experience of working in and providing support in a busy, fast-paced environment
  • Experience of coaching and advising line managers in all aspects of employee relations

Required Skills

  • Excellent communication skills
  • Sound grounding in the broad HR skillset and up to date knowledge of HR developments
  • Focus and flexibility; comfortable with change and ability to adapt advice to each individual situation
  • Emotional resilience; ability to challenge and provide guidance / advice at an appropriate level taking into account different perspectives
  • Strong organisational and interpersonal skills, particularly strong attention to detail
  • Up to date and strong knowledge of Employment Law
  • Effective team member in a multi-disciplined team
  • Strong negotiator with ability to see multiple viewpoints and apply advice in right way
  • Functional expert with drive to be a commercial influence for the success of the business

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QC Scientist (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. We have leveraged our 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.

Due to the increase in business, we are now looking to recruit QC Scientists to join our team in Livingston.

Experience 

  • Educated to degree level
  • Experience working within a QC laboratory to cGMP
  • Aseptic technique
  • Writing and working to SOP documentation
  • Analytical methods experience in a production-focused environment including Haemagglutination assay, ELISA, dye binding colorimetric assays (Bradford Method, Coomassie Plus), Electrophoresis, Cell Culture, Plaque assay, Western Blot.
  • Assay development, validation and transfer experience
  • Experience of working within Quality Management Systems which include deviations, change controls and CAPA’s

Responsibilities 

  • Execute analytical procedures, for testing of raw materials, intermediate products and final products, according to defined SOPs and protocols
  • Ensure that all necessary training is complete in the procedures conducted, and operate in compliance with 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
  • Ensure the laboratories are in a constant state of inspection readiness
  • Ensure that at any time equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Support change controls, investigations and CAPA’s
  • Identify areas for continuous improvement and escalate those to Line Manager
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Storage of in process, and final products samples including, for stability and retention purposes
  • Preparation of SOPs (where applicable) in accordance with Valneva Quality systems
  • Perform filing duties and other QC administrative duties as required by the line manager
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Shift work and out of hours work as required

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Head of Commercial Operations, France & Benelux (Lyon, France)

  • Requisition ID: FR-HCOMOP
  • Position: Full time
  • Location: Lyon, France
  • Required degrees: Degree in Business or Life Sciences. MBA preferred.

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Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers.

Job Description

Valneva’s French subsidiary was created in 2019 and extended to Benelux in 2020. The Head of Commercial Operations manages Valneva’s commercial sales in France and Benelux, including executing defined commercial strategies, managing local team and delivering on sales and profitability objectives. The incumbent will ensure operational and compliance performance according to Corporate objectives as well as applicable internal and external regulations.

Key Responsibilities

  • Deliver on financials: P&L responsibility in the territory in-line with approved budget (sales, OPEX)
  • Develop and oversee execution of country (or regional) product commercialization strategies and plans
  • Develop and execute local Business and Marketing Plans – clearly define strategic and tactical plans corresponding to achievement of sales budget and in alignment with Global Brand Plans and campaigns
  • Manage the local commercial operating business including day-to-day leadership of local teams functionally reporting to global functions (e.g. S&Ops planning, distribution logistics, Quality & Regulation Compliance, Finance)
  • Represent the Company and establish strong relationships with KOLs, customers and other key stakeholders according to Company policies and procedures, as well as local regulations
  • Manage commercial agreements with distribution and logistics partners, ensuring business performance based on agreed contractual terms, business continuity and sustainability
  • Ensure effective quality oversight of internal and external sales, marketing, distribution and logistics activities verifying that systems, procedures and standards are defined, being adhered to, are operating effectively and comply with local regulatory requirements
  • Take part in scientific integrity and compliance of promotional materials and specifically clinical data used in collaboration with the Pharmacien Responsable.
  • Recruit, manage and develop employees, including marketing and sales force, such that the entity is adequately provided with trained, motivated staff who are able to meet requirements
  • Provide input and guidance to Global Marketing & Medical functions to support constructive collaboration and development of global campaigns
  • Scan for and identify product in-licensing opportunities to enhance the local product offering

Profile

  • A minimum of ten years’ experience in general business management and/or sales & marketing and financial oversight in the pharmaceutical industry/life science sector
  • Knowledge of the vaccine market structure and stakeholders (i.e., customers, KOLs, agencies, etc.) in France; such knowledge related to Belgium, the Netherlands and Luxembourg is strongly preferred
  • Proven experience in networking and negotiating at the executive level in the vaccine field
  • Experience and knowledge in the vaccine sector preferred
  • Degree in Business or Life Sciences, MBA preferred
  • Proven experience in people management

Contract

  • Permanent, full-time position based in Lyon, France.
  • Travel is national and International

Contact

arnaud.corlosquet@valneva.com – Reference FR-HCOMOP

Company Highlights

Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

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QC Technician, Analytical (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

Due to the increase in business, we are now looking to recruit QC Technicians (Analytical) to join our team in Livingston.

Experience

  • Working within a QC laboratory to cGMP
  • Aseptic technique
  • Writing and working to SOP documentation
  • Analytical methods experience in a production-focused environment including Haemagglutination assay, ELISA, dye binding colorimetric assays (Bradford Method, Coomassie Plus), Electrophoresis, Cell Culture, Plaque assay, Western Blot.
  • Assay development, validation and transfer experience
  • Experience of working within Quality Management Systems which include deviations, change controls and CAPA’s

Responsibilities

  • Execute analytical procedures, for testing of raw materials, intermediate products and final products, according to defined SOPs and protocols
  • Ensure that all necessary training is complete in the procedures conducted, and operate in compliance with 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
  • Ensure the laboratories are in a constant state of inspection readiness
  • Ensure that at any time equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Support change controls, investigations and CAPA’s
  • Identify areas for continuous improvement and escalate those to Line Manager
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Storage of in process, and final products samples including, for stability and retention purposes
  • Preparation of SOPs (where applicable) in accordance with Valneva Quality systems
  • Perform filing duties and other QC administrative duties as required by the line manager
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Shift work and out of hours work as required

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Facility Engineers (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

Due to the increase in business we are currently recruiting Facility Engineers in Scotland.

Job Summary

To supervise and 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

You Will Have:

  • Engineering degree 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 and calibration programs
  • 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

Additional Required Skills:

  • Good communication and skills
  • Ability to work on own initiative and as part of a team

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QC Coordinator – Logistics 12 month FTC (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 600 employees.

A vacancy has arisen within Valneva Scotland’s Quality Control Department for a QC Co-ordinator (Logistics) for 12 month FTC

Job Summary 

We are looking for a positive and enthusiastic individual with a continuous improvement mind set to join and contribute to the QC team whilst maintaining compliance with our Quality Management System.

Out of hours working and/or overtime may be required due to business needs.

Key Responsibilities­

  • Organise testing and shipment of QC samples and materials to approved test houses, including Valneva Austria, using defined procedures
  • Align sample shipments and return of expected results to the manufacturing schedule whilst maintaining GMP compliance
  • Act as the Subject Master Expert (SME) for QC sample planning to coach/train others, as appropriate, to undertake the role at times of absence
  • Act as central point of contact for QC for the receipt of CofAs from Valneva Austria and approved test houses
  • Raise purchase requisitions for in process, final product, and raw material testing as required.
  • Co-ordinate the storage of QC samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
  • Co-ordinate the sampling of materials to support shipment schedules and analysis
  • Apply best GMP work-practices and techniques to sampling
  • Co-ordinate the release of raw materials ensuring the availability of materials to support the manufacturing, supply chain, and QC testing schedules
  • Write, manage and progress QMS documentation to meet agreed target dates
  • Immediately escalate and report deviations and issues through line management that may potentially impact sample shipment and/or analysis of materials required for the manufacturing schedule and QC testing schedules
  • Ensure allocated area(s) adhere to 5S working practices and high levels of cleanliness are maintained to ensure a state of inspection readiness
  • Identify continuous improvement opportunities and liaise with QC line management (or other functions) to agree benefits and deployment plans
  • Perform routine housekeeping activities in QC including cleaning of equipment and laboratory areas
  • Ensure that all required training is complete in procedures performed and operate in compliance with best GMP working practices at all times
  • Actively contribute to the development of the QC Logistics team, for example, through team meetings

Other Responsibilities

  • Deputise for the QC Raw Materials Co-ordinator and support the release of raw materials
  • Act as departmental point of contact on relevant site projects
  • Support other QC activities in line with the manufacturing schedule

Experience

  • Degree in biological sciences or relevant experience
  • Knowledge of GMP guidelines and regulatory bodies Biologics / vaccine background preferred
  • 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

Competencies

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

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QC Technician – Microbiology (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

An opportunity has arisen at Valneva Scotland for a QC Technician – Micro.

Job Summary

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

Responsibilities

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

Experience

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

Required Skills

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

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Engineering Technician (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Due to the increase in business we are currently recruiting for Engineer Technician to work at our Livingston site.

Job Summary

To execute defined procedures for calibration, qualification and maintenance of equipment / facilities, in compliance with applicable cGMP standards, regulations, techniques, best practice and business metrics.

Responsibilities

  • Perform routine calibrations and qualifications of various equipment ensuring compliance defined by SOPs, protocols and procedures
  • Apply cGMP / GEP work practices and techniques in compliance with regulatory requirements
  • Observe and assist in plant and facilities maintenance
  • 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
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Shift work and out of hours work as required
  • On Call rota

Job Requirements

  • ONC/HNC in an engineering discipline
  • Relevant work experience in a GMP environment preferred
  • Ability to work in a cleanroom environment
  • Good report writing skills

Required Skills

  • Good communication skills
  • Ability to work on own initiative and as part of a team
  • Reliable and enthusiastic

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QA Specialist – Document Management (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Do you have a background in Quality Assurance Document Management ? If so, we’d love to hear from you! Valneva is an award-winning, speciality vaccine company providing prevention against diseases with major unmet medical needs, and we are currently hiring for a QA Specialists within Document Management to join us during this unprecedented time of growth.

Job Summary

Responsible for document control and document archive.  Assist in maintaining a comprehensive quality management system to achieve inspection readiness all portfolio products

Responsibilities

  • Maintain a system of document control to meet the requirements of the company, taking into account any regulatory requirements i.e. GDP I cGMP I FDA
  • Maintain company archive and pre archive system to ensure adequate and secure protection of quality documentation and data.
  • Manage databases within the Quality System
  • Good Manufacturing Practice for the manufacture and testing of pharmaceuticals
  • Provide support during audits of Valneva Scotland Ltd
  • Support and take part in Continuous Improvement activities
  • Provide support for Pilgrim electronic document management system where required
  • Perform training in areas of expertise where required
  • Work within the Global Quality team to ensure efficient and effective roll-out of Global Quality Documents
  • Support Quality Assurance activities as directed by line manager or Head of Quality Assurance
  • Provide administrative support for Quality Assurance activities as directed by line manager or Head of Quality Assurance
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Job Requirements

Experience:

  • Relevant experience in business administration/ document control and archiving
  • Experience of GMP environment and specifically Quality Operations/ Quality Assurance

Required Skills:

  • Self-motivated and conscientious team player
  • Effective communication skills
  • Excellent organisational skills

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Validation Specialist (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

Valneva have a number of opportunities for Individuals with previous validation experience for our newly built manufacturing premises in Livingston.

Job Summary 

We are actively recruiting for Validation Specialists to assist with the definition and performance of operational validation activities that ensure that validation activities are in compliance with EU/FDA regulatory requirements and applicable guidelines.

Perform, witness and provide support and advice for required validations and qualifications on site. Acting as subject matter expert in regulatory inspections as appropriate based on involvement within the validation or project activities.

You will be responsible for:

  • Reporting to the Head of Validation, assist in the operational validation activities, including physically performing Equipment and Facility Qualifications.
  • Identify areas of improvement for validation systems/procedures and to provide support with the implementation of such improvements.
  • Generate and complete validation documentation in accordance with relevant Standard Operating Procedures, including but not limited to:
  • Validation Plans
  • Validation Protocols
  • Validation Reports
  • Participate in project groups and set acceptance criteria and define the data requirements necessary to ensure that validation work is compliant.  To ensure that the Head of Validation and other key stakeholders are informed of validation matters which may have an adverse impact on the validation status of facilities, equipment systems, the manufacturing process on product disposition (e.g. batch/lot release decisions).
  • Investigate and report Quality Issues, escalating to management as required.
  • To compile key quality data for the validation program and to make such data available to management to drive a culture of continuous improvement that is fully compliant with current EU/FDA regulations and quality requirements and Valneva Scotland Ltd business needs.
  • To keep up to date with current guidelines and regulatory requirements in respect of internal and external quality requirements.
  • To provide and/or coordinate training in validation related procedures/concepts as appropriate to meet business needs.
  • Provide support during internal/external and third-party audits.
  • Any other reasonable duties as requested by the Head of Validation Scotland.

Education / Experience:

  • HND level or equivalent qualification in relevant subject (required).
  • Working knowledge of Equipment Qualification and/ or Facility Qualification in a biopharmaceutical or pharmaceutical GMP environment (required).
  • Working knowledge of validation principles in at least one of the following (preferred):
  • Validation of aseptic processes (including filling),
  • Validation of Computerised systems,
  • Process Validation,
  • Assay Validation,
  • Cleaning Validation.
  • Experience in regulatory inspections (preferred).

You will have:

  •  Effective communication skills across all personnel levels within the organisation and with contractors / external engineers.
  • Good Writing skills for completion of documentation and report writing.
  • Good working knowledge of Microsoft Office including Word, Excel and PowerPoint.
  • A logical approach to problem solving
  • Good organisational and effective prioritisation skills
  • Ability to operate with minimal direct supervision

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Manufacturing Assistant – Cleanroom (Livingston, Scotland)

  • Position: Full time
  • Location: Livingston, Scotland

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Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

Valneva have a number of opportunities for Individuals with previous clean-room cleaning experience for our newly built manufacturing premises in Livingston.

Job Summary

We are looking for people to appropriately carry out all cleaning activities related to production support for ourCOVID-19 Vaccine Manufacturing Programme, according to set procedures and protocols and to best cGMP work practices and quality standards.

You will be responsible for:

  • Carrying out routine cleaning of the commercial manufacturing facility (and CTM facility as required) to a defined schedule of activities
  • Ensuring housekeeping within the cleanroom suites and common areas is maintained to a high standard at all times
  • Ensuring that response cleans are completed in a timely manner and to appropriate standards
  • Processing of orders picked from stores into the cleanroom to ensure manufacturing schedule adherence and contamination control
  • Supporting our Manufacturing activities by processing return of cleanroom garments, mops and other items as required
  • Applying best cGMP work practices and techniques
  • Immediately escalating and reporting any deviations involving materials, facilities, processes or procedures to line management
  • Conducting all activities in a careful and safe manner and in full compliance with HSE requirements
  • Supporting QMS investigations and any corrective actions and improvement opportunities
  • Identifying areas for continuous improvement and escalating those to the line manager
  • Actively contributing to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting
  • Participating in training of staff in areas of expertise
  • Be flexible to work shifts and out of hours work as required
  • Undertake any other duties as requested by the line manager in accordance with company requirements

You will have:

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

Additional Required Skills:

  • Excellent attention to detail
  • Ability to follow SOPs

Please Note:

As this role involves working in our cleanroom environment, you will be required to undergo a Health Screening procedure with a suitably qualified Doctor as part of our recruitment process.  We also conduct a Disclosure Scotland Check on all prospective new hires.

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Sample Manager Quality Control (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Location: Vienna, Austria
  • Required degrees: Bachelor/HTL degree in natural sciences

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Valneva is a specialty vaccine company focused on prevention against infectious diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

YOUR RESPONSIBILITIES

  • Responsible for sample management for in-house and external release and stability testing for QC departments
  • Organization of Incoming and Outgoing Shipments (Supply Coordinator)
  • Samples storage and distribution for internal testing
  • Maintain oversight and coordination of external testing
  • Maintain communication/contact with external and internal clients
  • Responsible for Purchase Order processing
  • Establishment of in house testing schedule and Certificates of Analyses
  • Archiving/filing of documents according to GMP requirements
  • Support basic lab equipment maintenance and calibration activities

YOUR QUALIFICATIONS

  • Bachelor/HTL degree in natural sciences
  • Excellent organizational, documentation management and teamwork skills required
  • High communicational skills required
  • Working experience in a laboratory or quality (GxP) environment is a plus
  • English fluently in word and writing, Experience with Word and Excel
  • Management and consolidation of large data sets/lists
  • Highly team-orientated personality
  • Willing to work in a high-quality regulated GxP 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 € 34.000,- 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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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