Process Validation Engineer
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Continued Process Verification (CPV) Engineer | CAR-T EMEA
To support the continued growth of the CAR-T program across EMEA, we are looking for a CPV Engineer to join the MSAT team, working closely with the Tech Transfer workstream.
Key Responsibilities
Continued Process Verification (CPV)
Support generation of the Annual Stage 3 CPV report - gathering data, drafting sections, and routing for approval alongside two lead engineers
Extract and structure manufacturing and analytical data from MES, LIMS, and SAP for key CAR-T metrics such as cell viability, harvest yield, and transduction efficiency
Perform routine data entry and initial statistical analysis (JMP or Minitab) to monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
Identify and flag Out-of-Trend (OOT) data or process variations for further investigation
Coordinate cross-functionally with QA and MSAT specialists to track down missing batch documentation and deviation updates
Particle Governance
Map the as-is particle monitoring process across the CAR-T manufacturing workflow, including sampling points, inspection methods, and data flows
Trend and track historical and real-time visible and sub-visible particulate data; investigate deviations and root causes
Design the to-be governance framework, including enhanced monitoring strategies and stricter alert/action limits
Present technical data, trending reports, and proposed frameworks to the Particle Governance Board
What You Bring
Experience in pharmaceutical, biotechnology, cell therapy, or human plasma-derived products (or a related industry)
Experience introducing products to manufacturing sites, with working technical knowledge of site unit operations
Strong working knowledge of cGMP
Cleanroom/aseptic environment experience is a plus, not a requirement
Solid project management and reporting skills
Ability to work independently, prioritize effectively, and perform under pressure
Strong problem-solving skills and a team-oriented mindset
Fluent in both Dutch and English (written and spoken)
5–7 years of relevant experience
Bachelor's degree or higher in Engineering, Biotechnology, Biomedical Sciences, or Pharmacy
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