Process Validation Engineer Cell Therapy

pJobs / Process Validation Engineer Cell Therapy /ph3bProcess Validation Engineer Cell Therapy /b /h3pAt MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare. /ppYou can count on: /pulliA competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card /liliPersonal growth support with tailored training and clear career development /liliA stable environment where your technical skills directly contribute to improved patient care /liliThe chance to work with high tech diagnostic systems at top tier healthcare institutions /liliA warm and collaborative culture focused on trust, ownership and long term impact /li /ulpAs Process Validation Engineer, you will coordinate validation activities within a new manufacturing environment. Your scope includes process validation, sterilisation validation, technology transfer, equipment introduction and technical documentation while ensuring compliance with current regulatory and GMP requirements. /ppbKey responsibilities /b /pulliValidation strategy: Define, plan and coordinate PPQ, smoke studies, hold time validation, APQ and APS activities. /liliValidation guidance: Provide technical guidance on validation and qualification activities. /liliRevalidation: Ensure timely revalidation of manufacturing and sterilisation processes. /liliDocumentation: Write, review and approve validation plans, protocols and reports. /liliTechnology transfer: Participate in product transfer and manufacturing system introduction activities. /liliProcess improvement: Contribute to optimisation projects for manufacturing systems and processes. /liliCompliance review: Review technical documentation against regulatory requirements and current industry practices. /liliProject reporting: Provide accurate and timely progress updates to stakeholders and leadership. /liliLead validation activities for advanced cell therapy /liliSupport tech transfer and manufacturing process activities /liliDrive compliant validation within a regulated environment /liliManage material lifecycle act across quality and operations /liliImprove compliance, continuity, cost control and OPEX /liliOptimise processes, data and systems using digital tools /liliBuild practical experience in CSV projects /liliSupport validation activities within GMP environments /liliLead commissioning across complex systems /liliCoordinate testing, acceptance and operational handover /liliEnsure safe execution within strict regulated environments /liliTechnical field support for diagnostic systems /liliRegional role with customer interaction /liliIdeal for junior engineers who want impact /liliExecute validation of GMP critical computerised systems /liliEnsure compliance with FDA and EU regulatory standards /liliGenerate validation documentation and resolve issues /liliQualify and validate equipment and processes /li /ulh3Required competences skills /h3ulliEducation: Bachelor degree or higher in engineering, biotechnology, biomedical sciences or pharmacy. /liliIndustry

experience:
Experience within pharmaceutical, biotechnology, cell therapy or a related regulated industry. /liliManufacturing knowledge: Experience introducing pharmaceutical products into manufacturing environments. /liliTechnical expertise: Working knowledge of manufacturing operations and late stage development activities. /liliGMP knowledge: Strong working knowledge of current Good Manufacturing Practices. /liliAseptic

experience:
Experience within controlled cleanroom environments under aseptic conditions is a plus. /liliProject management: Ability to manage activities, priorities and reporting in a structured way. /liliProblem solving: Strong decision making and problem solving skills under changing priorities. /liliCollaboration: Ability to work independently while interacting effectively across organisational levels. /liliLanguages: Fluent written and spoken Dutch and English. /li /ulpbCQV /b bGhent /b bMedior /b bAt MindCapture as consultant /b /ph3About this application /h3pThis opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client. /ppMindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way. /ph3Job Contact – bTalent Business Team /b /h3pOur Talent Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind. /ppWhen a potential match is identified, one of our TB