CAR-T Validation Engineer – On-Site in Ghent (Hybrid)

Sentior, Ltd.; Oost-Vlaanderen; Hybride; EUR 69 000 - 96 000; Plein temps

Résumé du poste

Johnson & Johnson in Ghent, Belgium, seeks a Process Validation Engineer to shape a new CAR-T T-cell therapy production process. You will define strategy, coordinate validation activities and ensure compliance with regulatory standards.

The role is on-site with occasional work-from-home, 40 hours per week, starting ASAP through 31 December 2027. You must have 2–6 years in validation within pharma or biotech, strong cGMP knowledge, and a degree in engineering/biotech/biomedical sciences or

Qualifications

• Experience in Pharmaceuticals, Biotechnology or Cell Therapy required.
• Good knowledge of cGMP and aseptic manufacturing.
• 2–6 years of validation experience, including PPQ, smoke studies and PPQ support.
• Project management skills with ability to report to peers and leadership.
• English proficiency mandatory; Dutch proficiency considered a bonus.

Responsabilités

• Define strategy, plan and coordinate validation activities such as PPQ, smoke studies, hold time validation, APQ and APS.
• Provide guidance on validations and qualifications and revalidate manufacturing and sterilization processes.
• Write, review and approve validation plans, protocols and reports.
• Participate in product transfer, system introduction and process improvement projects.
• Ensure validations align with current regulatory requirements and technology.

Description du poste

Johnson & Johnson in Ghent, Belgium, seeks a Process Validation Engineer to shape a new CAR-T T-cell therapy production process. You will define strategy, coordinate validation activities and ensure compliance with regulatory standards.

The role is on-site with occasional work-from-home, 40 hours per week, starting ASAP through 31 December 2027. You must have 2–6 years in validation within pharma or biotech, strong cGMP knowledge, and a degree in engineering/biotech/biomedical sciences or