Process Validation Engineer
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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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