Process Validation Specialist

il y a 2 jours


CorbeilEssonnes, Île-de-France Yposkesi Temps plein
About the Role

We are seeking a highly skilled Process Validation Lead to join our Technical Development team at Yposkesi. As a key member of our team, you will be responsible for developing and executing process validation strategies for our gene therapy manufacturing processes.

Key Responsibilities
  • Develop and implement process validation strategies for drug substance and drug product manufacturing processes
  • Execute process validation studies, including defining, writing, and approving supporting documentation
  • Collaborate with cross-functional teams, including Manufacturing and Quality, to ensure alignment and effective execution
  • Participate in the site APS committee to define and manage the site APS strategy and activities
  • Build and lead a process validation team to support the growth of our ProVal activities
  • Maintain alignment with client and regulatory expectations for validation of biomanufacturing and gene therapy manufacturing processes
  • Represent process validation activities in meetings with clients and international consortia
Requirements
  • MSc in Biochemical Engineering, Biotechnology, or life sciences
  • 3-5 years of experience in an applied setting, with experience of working in multi-disciplinary teams
  • Good oral and written English skills (B2 level); intermediate level in French (B1 - B2)
  • Solid understanding of biomanufacturing processes, including drug substance and drug product
  • Strong understanding of biomanufacturing process design, development, characterisation, and validation
  • Previous experience in development of process validation strategies required
What We Offer

As a Process Validation Lead at Yposkesi, you will have the opportunity to work on exciting projects in the field of gene therapy and biomanufacturing. You will be part of a dynamic team and will have the chance to develop your skills and expertise in process validation.



  • Corbeil-Essonnes, Île-de-France Yposkesi Temps plein

    About the RoleWe are seeking a highly skilled Process Validation Lead to join our Technical Development team at Yposkesi. As a key member of our organization, you will be responsible for developing and executing process validation strategies for our gene therapy manufacturing processes.Key ResponsibilitiesDevelop and implement process validation strategies...


  • Corbeil-Essonnes, Île-de-France Yposkesi Temps plein

    About the RoleWe are seeking a highly skilled Process Validation Lead to join our Technical Development team at Yposkesi. As a key member of our organization, you will be responsible for developing and executing process validation strategies for our gene therapy manufacturing processes.Key ResponsibilitiesDevelop and implement process validation strategies...


  • Corbeil-Essonnes, Île-de-France Yposkesi Temps plein

    About the RoleWe are seeking a highly skilled Process Validation Lead to join our Technical Development team at Yposkesi. As a key member of our organization, you will be responsible for developing and executing process validation strategies and systems for our gene therapy manufacturing processes.Key ResponsibilitiesDevelop process validation strategies and...


  • Corbeil-Essonnes, Île-de-France Yposkesi Temps plein

    About YposkesiYposkesi, a part of SK pharmteco, stands as one of Europe's premier Contract Development and Manufacturing Organizations (CDMO) specializing in gene therapy viral vector production. We provide comprehensive services for biotech and pharmaceutical enterprises aiming to propel clinical trials and bring Advanced Therapy Medicinal Products (ATMPs)...


  • Corbeil-Essonnes, Île-de-France Yposkesi Temps plein

    About UsYposkesi, a part of SK pharmteco, stands as one of the foremost Contract Development and Manufacturing Organizations (CDMO) in Europe, specializing in the production of gene therapy viral vectors. We serve as a comprehensive partner for biotech and pharmaceutical enterprises aiming to progress clinical trials and bring Advanced Therapy Medicinal...

  • Process Validation Lead

    il y a 2 semaines


    Corbeil-Essonnes, Île-de-France Yposkesi Temps plein

    About YposkesiYposkesi, a leading Contract Development and Manufacturing Organization (CDMO), specializes in gene therapy viral vector manufacturing. As a one-stop shop for biotech and pharmaceutical companies, we offer a comprehensive range of services in lentiviral vector and AAV (Adeno-Associated Virus) vector development and cGMP manufacturing.Our...


  • Corbeil-Essonnes, Île-de-France Yposkesi Temps plein

    About UsYposkesi, a part of SK pharmteco, stands as one of Europe's premier Contract Development and Manufacturing Organizations (CDMO) specializing in the production of gene therapy viral vectors. We provide comprehensive services for biotech and pharmaceutical enterprises aiming to propel clinical trials and bring new Advanced Therapy Medicinal Products...


  • Corbeil-Essonnes, Île-de-France X-FAB Silicon Foundries Temps plein

    Job SummaryX-FAB Silicon Foundries is seeking a highly skilled Development Process Integration Engineer to join our team. As a key member of our process development team, you will be responsible for designing, developing, and implementing semiconductor processes and components using X-FAB group technologies.Key ResponsibilitiesCollaborate with process...


  • Corbeil-Essonnes, Île-de-France X-FAB Silicon Foundries Temps plein

    X-FAB Silicon Foundries is a leading analog/mixed-signal foundry that manufactures silicon wafers for integrated circuits. As a key member of our team, you will contribute to the development of high-performance technologies and provide excellent technical design and prototyping services to our customers.Key Responsibilities:Collaborate with the Level 2...


  • Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps plein

    ObjectiveTo design, validate, and sustain manufacturing processes and metrics that ensure product functionality and quality, alongside optimizing the industrial performance of related operations.Key ResponsibilitiesEnsure compliance with product specifications throughout all phases of production.Implement Statistical Process Control (SPC) and Fault Detection...


  • Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps plein

    ObjectiveTo develop, validate, and sustain manufacturing processes and metrics that ensure product functionality and quality, alongside optimizing the industrial performance of related operations.Key ResponsibilitiesEnsure adherence to product specifications throughout all phases of production.Implement Statistical Process Control (SPC) and Fault Detection...


  • Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps plein

    ObjectiveTo develop, validate, and sustain manufacturing methodologies and metrics that ensure product functionality and quality, alongside optimizing the industrial efficiency of related operations.Key ResponsibilitiesEnsure compliance with product specifications throughout all phases of production.Implement Statistical Process Control (SPC) and Fault...


  • Corbeil-Essonnes, Île-de-France Ligentec SA Temps plein

    Company OverviewLIGENTEC is a rapidly expanding European enterprise headquartered in Lausanne, Switzerland. Our recent growth includes the establishment of LIGENTEC France, enhancing our manufacturing capabilities. We focus on the design and production of Photonic Integrated Circuits (PICs) tailored for clients in advanced sectors such as Quantum...

  • Recruitment Specialist

    il y a 4 semaines


    Corbeil-Essonnes, Île-de-France MOULINS SOUFFLET Temps plein

    About EpisensEpisens is a leading company in the grain-to-finished product sector, bringing together expertise in milling, ingredients, and industrial bakery. Our mission is to develop sustainable supply chains through our Semons du Sens approach.About Moulins SouffletMoulins Soufflet is a prominent French miller and a subsidiary of Episens. We uphold...


  • Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps plein

    Job SummaryWe are seeking a highly skilled Industrial Equipment Specialist to join our team at X-FAB France SAS. As a key member of our Maintenance & Equipment organization, you will be responsible for ensuring the performance and availability of our production equipment.Key ResponsibilitiesDevelop and implement maintenance strategies to optimize equipment...


  • Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps plein

    Job SummaryWe are seeking a highly skilled Industrial Equipment Specialist to join our team at X-FAB France SAS. As a key member of our Maintenance & Equipment organization, you will be responsible for ensuring the performance and availability of our production equipment.Key ResponsibilitiesDevelop and implement maintenance strategies to optimize equipment...


  • Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps plein

    Job SummaryWe are seeking a highly skilled Industrial Equipment Specialist to join our team at X-FAB France SAS. As a key member of our Maintenance & Equipment organization, you will be responsible for ensuring the performance and availability of our production equipment.Key ResponsibilitiesDevelop and implement maintenance strategies to optimize equipment...


  • Corbeil-Essonnes, Île-de-France Templeton & Partners - Innovative & Inclusive Hiring Solutions Temps plein

    Job Title: DevOps Engineer – CI/CD and Cloud Infrastructure SpecialistWe are seeking a skilled DevOps professional to join our team at Templeton & Partners - Innovative & Inclusive Hiring Solutions. This role focuses on ensuring the smooth delivery of SaaS solutions while collaborating with product owners and technical leads to enhance and implement...


  • Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps plein

    Job SummaryWe are seeking a highly skilled Industrial Equipment Specialist to join our team at X-FAB France SAS. As a key member of our Maintenance & Equipment organization, you will be responsible for ensuring the performance and availability of our production equipment.Key ResponsibilitiesDevelop and implement action plans to improve the efficiency of our...


  • Corbeil-Essonnes, Île-de-France ATEXIS Temps plein

    Exciting Opportunity for an Industrial PilotWe are on the lookout for an Industrial Pilot to collaborate closely with one of our prominent clients in the aerospace industry. In this role, your key responsibilities will encompass:Managing and coordinating all parties involved in the industrialization processFacilitating meetings for upcoming industrialization...