CAR-T Process Validation Engineer

Capgemini; Diegem; Hybride; EUR 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

Hybrid working

Learning platforms

Mentoring programs

FlexAbroad

Résumé du poste

Capgemini Engineering in Belgium seeks a Process Validation Engineer to drive validation activities for CAR-T cell therapy manufacturing in Ghent. You will define strategy, coordinate validation efforts, and ensure compliance with regulatory standards while supporting the transfer of this innovative therapy to Belgium.

The role offers collaboration with cross-functional teams, exposure to sterile manufacturing, and opportunities to optimize processes in a fast-paced environment.

Qualifications

• Master's degree in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or related discipline.
• 2–5 years of experience in Pharmaceutical/Biotechnology/Cell Therapy.
• Experience with cGMP, process validation methodologies, and sterilization validation.

Responsabilités

• Define strategy, planning, and coordinate validation activities including hold time validation, APQ, APS, smoke studies, and process validation.
• Provide expert guidance on validation and qualification activities; assure revalidation of manufacturing and sterilization processes.
• Write, review, and approve process validation plans, protocols, and reports with focus on accuracy and compliance.
• Participate in product transfer and system introduction teams, supporting the CAR-T pilot plant in Ghent.
• Engage in system and process improvement across manufacturing operations; review technical reports for cGMP compliance.

Connaissances

cGMP knowledge

Process validation

Sterilization validation

Documentation

Cross-functional teamwork

English fluency

Dutch fluency

Formation

Master's degree in Engineering/biotech/pharmacy

Description du poste

Capgemini Engineering in Belgium seeks a Process Validation Engineer to drive validation activities for CAR-T cell therapy manufacturing in Ghent. You will define strategy, coordinate validation efforts, and ensure compliance with regulatory standards while supporting the transfer of this innovative therapy to Belgium.

The role offers collaboration with cross-functional teams, exposure to sterile manufacturing, and opportunities to optimize processes in a fast-paced environment.