QA Commissioning & Qualification Engineer

Pauwels Consulting; Oost-Vlaanderen; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a CAR-T QA C&Q Engineer to ensure qualification and compliance for critical production assets in a leading cell therapy setting in Belgium. You will manage qualification status for facilities, utilities and process equipment and act as quality process expert during inspections.

You will review change controls, protocols, reports and URS, investigate equipment deviations and drive CAPAs, while coordinating with regulatory bodies and international teams.

Qualifications

• Master's degree in Engineering (Chemistry/Analytical) or Pharmaceutical Sciences.
• Experience in equipment qualification including C&Q, facilities, utilities and process equipment.
• Knowledge of cGMP regulations and FDA/EU guidelines.
• Experience with computerized systems, parameter configurations and data integrity.
• Proactive with strong analytical thinking, risk assessment and collaboration skills.
• Fluent in Dutch and English.

Responsabilités

• Review and approve qualification and requalification activities for facilities, utilities and process equipment.
• Ensure the qualification status of critical production assets and identify system critical aspects with mitigation plans.
• Investigate deviations related to equipment issues and define CAPAs.
• Review calibration records, maintenance plans and data integrity deliverables to manage compliance status.
• Approve qualification documentation including change controls, protocols, reports, SOPs and 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.

Connaissances

Analytical thinking

Risk assessment

Collaboration

Dutch language

English language

Formation

Master's degree in Engineering (Chemistry/Analytical)

Master's degree in Pharmaceutical Sciences

Outils

Computerized systems

Description du poste

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.