CAR-T Process Validation Engineer (Hybrid, Ghent)

Capgemini Engineering; Diegem; Hybride; EUR 55 000 - 90 000; Plein temps

Avantages offerts par ce poste

Hybrid working

Mentoring programs

Free learning platforms

Global company

Résumé du poste

Capgemini Engineering seeks a Process Validation Engineer to support start-up and scale-up of CAR-T therapy manufacturing in Ghent. You will collaborate with cross-functional teams to ensure regulatory and quality standards for validation activities and support US-to-Belgium transfers.

You will define validation strategies, write plans and oversee reports, while contributing to transfer projects and site improvements in a highly regulated environment.

Qualifications

• Master's degree in Engineering, Biotechnology, Biomedical Sciences, Pharmacy or related discipline.
• 2–5 years in Pharmaceutical/Biotech/Cell Therapy with manufacturing exposure.
• Strong knowledge of cGMP and validation; aseptic environment experience a plus.

Responsabilités

• Define strategy and plan validation activities (hold time, APQ, APS, smoke studies, process validation).
• Provide expert guidance on validation and qualification; ensure revalidation of processes.
• Write, review and approve validation plans, protocols and reports with accuracy and compliance.
• Support product transfer and system introduction for the CAR-T pilot plant in Ghent.
• Drive system/process improvements to boost efficiency, quality, and compliance.
• Review technical reports to ensure adherence to cGMP and regulatory requirements.

Connaissances

Problem solving

Teamwork

Communication

Independent work

Formation

Master's degree

Description du poste

Capgemini Engineering seeks a Process Validation Engineer to support start-up and scale-up of CAR-T therapy manufacturing in Ghent. You will collaborate with cross-functional teams to ensure regulatory and quality standards for validation activities and support US-to-Belgium transfers.

You will define validation strategies, write plans and oversee reports, while contributing to transfer projects and site improvements in a highly regulated environment.