Senior QA Engineer, MES for CAR‑T Manufacturing

7555-Janssen Pharmaceutica NV Legal Entity; Oost-Vlaanderen; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a Senior QA Engineer MES – CAR-T Europe to ensure compliant lifecycle of electronic master batch records for our Ghent CAR-T manufacturing hub and cryo center in Beerse.

You will provide QA oversight, review verification documentation, collaborate with MES, QA Operations, IT and project teams, and drive timely, inspection-ready deliverables across GMP and data integrity requirements.

Qualifications

• Bachelor's or master's in bioengineering, pharmacy or a related field.
• At least five years in the pharmaceutical industry with GMP experience.
• Hands-on with MBR verification and MES in manufacturing.

Responsabilités

• Provide QA oversight of MES MBR verification activities.
• Review and approve design docs, test plans and PQ protocols.
• Lead audit readiness and represent QA MES in projects.
• Ensure data integrity and compliance with GMP and procedures.
• Collaborate with MES, QA Operations, IT and project teams.

Connaissances

Cross-functional collaboration

Analytical thinking

Decision making

Independent work

AI concepts awareness

Formation

Bachelor's or Master's in bioengineering/pharma

Outils

MES systems (PAS-X)

Opstracker

Description du poste

Johnson & Johnson Innovative Medicine is seeking a Senior QA Engineer MES – CAR-T Europe to ensure compliant lifecycle of electronic master batch records for our Ghent CAR-T manufacturing hub and cryo center in Beerse.

You will provide QA oversight, review verification documentation, collaborate with MES, QA Operations, IT and project teams, and drive timely, inspection-ready deliverables across GMP and data integrity requirements.