CAR-T QA C&Q Engineer

Our client, a leader in innovative pharmaceutical solutions, is seeking a CAR-T QA C&Q Engineer to join their specialized quality team. This role focuses on the review and approval of qualification activities for facilities, utilities, and process equipment within a cutting-edge manufacturing environment.

• Review and approve qualification and requalification documentation, including protocols, reports, and URS for facilities and process equipment.
• Ensure the qualification status of critical production assets by identifying and controlling all system critical aspects related to process requirements.
• Investigate equipment-related deviations and implement effective CAPA plans to ensure continuous compliance and quality.
• Manage the compliance status of production assets through the review of calibration records, maintenance plans, and master data setup.
• Oversee data integrity deliverables by reviewing system audit trails and performing user access reviews for critical assets.
• Represent the QA qualification function as a technical expert during regulatory and customer inspections.
• Contribute to process improvement and optimization projects to ensure alignment with international regulations and industry practices.

• You have a Master’s degree in Engineering, Pharmaceutical Sciences, or a related analytical field.
• You bring knowledge of cGMP regulations and FDA/EU guidance related to pharmaceutical or cell therapy manufacturing.
• You possess experience in qualification and validation processes including change control, URS, and IA.
• You have affinity with computerized systems, including parameter configurations and data management in production environments.
• You bring strong analytical thinking, risk assessment skills, and a collaborative, solution-oriented mindset.
• You are fluent in Dutch and English.

Nice to Haves

• Experience acting as a subject matter expert during health authority inspections.
• Advanced knowledge of data integrity standards for production assets.

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