Remote CAR‑T Process Validation Engineer

AMARIS GROUP SA; Oost-Vlaanderen; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health Insurance

Remote work

Résumé du poste

Mantu is seeking a Process Validation Engineer (M/W/X) to support CPV and particle governance within the CAR-T EMEA program, joining our Life Sciences team.

You will extract and structure manufacturing data from MES, LIMS and SAP, perform routine data entry and statistical analysis, and help identify process drift and deviations. Collaboration with QA and MSAT is essential to maintain high standards of compliance.

Qualifications

• Experience in pharma/biotech/cell therapy environment.
• cGMP knowledge essential.
• Degree in engineering/biotech/biomedical sciences/pharmacy.

Responsabilités

• Support CPV report generation and data gathering.
• Extract and structure data from MES, LIMS, SAP.
• Perform routine data entry and statistical analysis (JMP/Minitab).
• Identify process drift and flag out-of-trend data or deviations.
• Coordinate with QA and MSAT on batch documentation and deviations.
• Map particle monitoring across CAR-T manufacturing workflow.

Connaissances

cGMP

Project management

Data analysis

Dutch fluency

English fluency

Formation

Bachelor’s degree in engineering/biotech

Outils

MES

LIMS

SAP

Description du poste

Mantu is seeking a Process Validation Engineer (M/W/X) to support CPV and particle governance within the CAR-T EMEA program, joining our Life Sciences team.

You will extract and structure manufacturing data from MES, LIMS and SAP, perform routine data entry and statistical analysis, and help identify process drift and deviations. Collaboration with QA and MSAT is essential to maintain high standards of compliance.