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Process Validation Engineer - Cell TherapyPanda International • Ghent, Flemish Region, BE
Process Validation Engineer - Cell Therapy

Process Validation Engineer - Cell Therapy

Panda International • Ghent, Flemish Region, BE
15 uur geleden
Functieomschrijving

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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Process Validation Engineer - Cell Therapy • Ghent, Flemish Region, BE

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