CAR-T QA C&Q Engineer

Pauwels Consulting; Oost-Vlaanderen; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Pauwels Consulting seeks a CAR-T QA C&Q Engineer to support advanced manufacturing operations. The role oversees qualification activities for facilities, utilities and process equipment, ensuring ongoing compliance and data integrity in a cGMP environment.

You will review deviations, CAPA plans and calibration records while maintaining asset qualification statuses and approving essential documentation. Regulatory inspections will be a key facet of the function.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, or related field.
• Knowledge of cGMP regulations and FDA/EU guidance for medicinal product manufacturing.
• Affinity for computerized systems including system parameter configurations and data management.
• Strong analytical thinking, risk assessment capabilities, and ability to work in a team.

Responsabilités

• Review and approve qualification and requalification activities for facilities, utilities, and process equipment.
• Maintain qualification status of critical production assets by identifying and controlling system-critical aspects.
• Evaluate and investigate deviations related to equipment issues; define and implement CAPA.
• Manage compliance status of production assets via review of calibration records, maintenance plans and master data.
• Oversee data integrity deliverables, including system audit trails and user access reviews.
• Approve essential documentation such as change controls, protocols, URS, and SOPs.
• Participate in regulatory inspections as a subject matter expert for quality assurance and qualification.

Connaissances

cGMP knowledge

FDA/EU guidance

Computerized systems

Analytical thinking

Risk assessment

Teamwork

Formation

Master's degree in Engineering/Pharmaceutical Sciences or related field

Description du poste

Our client, a prominent pharmaceutical organization, is seeking a CAR-T QA C&Q Engineer to support their innovative manufacturing operations. This role is responsible for the oversight and approval of qualification activities for facilities, utilities, and process equipment within a specialized therapeutic environment.

• Review and approve qualification and requalification activities for facilities, utilities, and process equipment.
• Maintain the qualification status of critical production assets by ensuring all system-critical aspects are identified and controlled.
• Evaluate and investigate deviations related to equipment issues, defining and implementing appropriate corrective and preventive actions.
• Manage the compliance status of production assets through the review of calibration records, maintenance plans, and master data.
• Oversee data integrity deliverables, including system audit trails and user access reviews.
• Approve essential documentation such as change controls, protocols, URS, and SOPs.
• Participate in regulatory inspections as a subject matter expert for quality assurance and qualification.

• You have a Master's degree in Engineering, Pharmaceutical Sciences, or a related field with a chemistry or analytical background.
• You possess knowledge of cGMP regulations and FDA/EU guidance related to the manufacturing of medicinal products.
• You bring an affinity for computerized systems, including system parameter configurations and data management.
• You have strong analytical thinking, risk assessment capabilities, and the ability to work effectively in a team.
• You are fluent in Dutch and English, both orally and in writing.

Nice to Haves

• Experience defending strategies and documentation during health authority inspections.
• Proven ability to work cross-departmentally in a continuously changing environment.