Process Validation Engineer

Continued Process Verification (CPV) Engineer | CAR-T EMEA

Make your application after reading the following skill and qualification requirements for this position.

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 xlxgzvr 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