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.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.