CPV Engineer, CAR-T MSAT – Data-Driven Process Validation

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

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.