CAR-T QA C&Q Engineer

Our client, a leading pharmaceutical organization specialized in innovative cell therapies, is seeking a CAR-T QA C&Q Engineer. This role focuses on ensuring the qualification status of critical production assets and managing compliance for facilities, utilities, and process equipment. The position involves acting as a quality process expert and supporting international regulatory inspections.

• Review and approve qualification and requalification activities for facilities, utilities, and process equipment.
• Ensure the qualification status of critical production assets by identifying system critical aspects and implementing mitigation plans.
• Investigate deviations related to equipment issues and define adequate corrective and preventive actions (CAPA).
• Manage compliance status through the review of calibration records, maintenance plans, and data integrity deliverables.
• Approve qualification documentation including change controls, protocols, reports, SOPs, and user requirement specifications (URS).
• Participate in system and process improvement projects while maintaining knowledge of international regulations and industry practices.
• Support regulatory and customer inspections as a spokesperson for quality assurance qualification.

• You have a Master's degree in Engineering (Chemistry or Analytical background) or Pharmaceutical Sciences.
• You bring experience in equipment qualification including C&Q, facilities, utilities, and process equipment.
• You possess knowledge of cGMP regulations and FDA/EU guidelines.
• You have experience with computerized systems, parameter configurations, and data integrity.
• You're proactive with strong analytical thinking, risk assessment, and collaboration skills.
• You are fluent in Dutch and English.

Nice to Haves

• Experience with cell therapy products.
• Knowledge of MAM (Make Asset Management) processes.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
• Versnel je carrière met een helder groeipad, coaching en mentoring ter ondersteuning.
• Werk in een dynamische en ondersteunende omgeving waar je echt het verschil kunt maken.
• Werk waar en wanneer je het beste presteert voor een ideale werk-privébalans.
• Kies een flexibele mobiliteitsoplossing, van een bedrijfswagen tot een openbaar vervoer abonnement.
• Bouw je netwerk uit en beleef onvergetelijke momenten tijdens exclusieve events en afterworks.
• Breid je vaardigheden uit met externe opleidingen en onze in-house Pauwels Academy.
• Werk aan uitdagende projecten met toonaangevende klanten in Life Sciences, Engineering & Digital.
• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.