CAR-T QA C&Q Engineer

Position: CAR-T QA C&Q Engineer

Location: Ghent Area, Belgium

About the Role:

This position is focused on supporting the CAR-T (Chimeric Antigen Receptor T-cell therapy) program, a groundbreaking approach to eliminate cancer cells by utilizing the patient's own immune system. The CAR-T program is expanding with two new manufacturing centers in the Ghent area, and the QA C&Q Engineer will play a crucial role in overseeing qualification and requalification activities related to critical production assets.

Key Responsibilities:

• Qualification and Requalification:
  Work closely with the MAM (Make Asset Management) and E&PS (Engineering & Process Systems) departments to ensure that all critical systems related to facilities, utilities, and process equipment are qualified and controlled.

• Deviation Management:
  Evaluate, investigate, and implement corrective and preventive actions for deviations that could impact quality and compliance, specifically related to equipment issues.

• Collaboration with Manufacturing:
  Approve new change controls and ensure that any deviations are thoroughly investigated, with adequate corrective actions put in place.

• Quality Compliance:
  Manage the compliance status of critical production assets by reviewing and approving calibration procedures, calibration records, maintenance plans, and data integrity deliverables (e.g., system audit trails and user access reviews).

• Document Review and Approval:
  Approve qualification documents such as change controls, protocols, reports, SOPs, and URS. Address discrepancies and non-conformances during the execution of qualification activities.

• Continuous Improvement:
  Participate in system and process improvement initiatives to ensure quality and compliance, while staying up-to-date with international regulations, guidelines, and industry practices.

Qualifications and Skills:

• Education:
  Master's degree in Engineering (Chemistry or Analytical background), Pharmaceutical Sciences, or a related field.

• Regulatory Knowledge:
  Strong awareness of cGMP regulations and FDA/EU guidelines for the manufacturing of cell therapy products. Ability to defend strategies and documents during health authority inspections.

• System and Data Management:
  Affinity for computerized systems, system parameter configurations, and data management in critical production assets.

• Communication Skills:
  Strong verbal and written communication skills in both Dutch and English. Able to communicate effectively in a cross-departmental, continuously changing environment.

• Analytical and Risk Management Skills:
  Ability to think analytically, perform risk assessments, and effectively communicate findings.

• Team Collaboration:
  Strong collaboration and teamwork skills, with a proven ability to work in a multidisciplinary environment.

About You:

The ideal candidate will be a detail-oriented, proactive professional with a solid background in engineering and quality assurance within a regulated environment. You should be comfortable managing compliance, driving continuous improvements, and working in a highly dynamic setting.