Senior QA Engineer, MES - CAR-T Europe
Johnson & Johnson
Johnson & Johnson seeks a Senior QA Engineer to oversee quality assurance for electronic master batch records supporting CAR-T cell therapy manufacturing in Ghent and cryopreservation operations in Beerse. The role involves quality oversight, regulatory compliance, documentation review, and cross-functional collaboration to ensure GMP-compliant manufacturing processes.
Responsibilities
- Serve as backup to QA MES Manager, supporting broader QA activities and strategic decisions
- Provide QA oversight of MES master batch record verification in compliance with procedures and timelines
- Review and approve quality project plans, MBR checklists, design documentation, test protocols, and go-live documentation
- Lead audit and inspection readiness activities, serve as QA spokesperson for regulatory interactions
- Review non-conformances, support root cause investigations, and approve MES-related change controls
Requirements
- Bachelor's or master's degree in bioengineering, pharmacy, or related technical/scientific discipline
- Minimum five years cross-functional pharmaceutical industry experience
- Strong knowledge of cGMP requirements and pharmaceutical regulations
- Hands-on experience with master batch records in GMP manufacturing environments
- Experience reviewing MBR verification or qualification documentation strongly preferred
- MES experience in manufacturing; PAS-X or Opstracker knowledge valued
- Strong analytical, communication and decision-making skills with solution-oriented approach
L'offre d'emploi a été publiée il y a 5 jours
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