Process Validation Engineer - Cell Therapy

Panda International; Gent; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Panda International is seeking a CPV Engineer to join the MSAT team to support the CAR-T program across EMEA. You will work on CPV governance, data extraction from MES/LIMS/SAP, and statistical monitoring of CPPs/CQAs.

The role requires 5–7 years in pharma/biotech, strong cGMP knowledge, and fluency in Dutch and English. Cleanroom experience optional but beneficial; Bachelor's or higher in Engineering, Biotechnology, Biomedical Sciences, or Pharmacy.

Qualifications

• Experience in pharma/biotech, cell therapy, or related industry.
• Experience introducing products to manufacturing sites with knowledge of site operations.
• Strong knowledge of cGMP and regulatory expectations.
• Cleanroom/aseptic environment experience is a plus.

Responsabilités

• Support Annual Stage 3 CPV report with data gathering, drafting sections and routing for approval.
• Extract and structure manufacturing/analytical data from MES/LIMS/SAP for CAR-T metrics like viability and yield.
• Perform routine data entry and statistics (JMP/Minitab) to monitor CPPs and CQAs.
• Identify and flag OOT data or process variations for investigation.
• Coordinate with QA and MSAT to track batch documentation and deviations.

Connaissances

Dutch language

English language

Project management

Problem solving

Formation

Bachelor's degree or higher in Engineering/Biomedical Sciences/Pharmacy

Description du poste

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