QA CAR-T Qualification Engineer (EMEA)

Johnson & Johnson Innovative Medicine; Oost-Vlaanderen; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Insurance plans

Job summary

Johnson & Johnson Innovative Medicines is recruiting a QA CAR-T Qualification Engineer for the CAR-T hub in Europe, supporting the Ghent area expansion. The role involves review and approval of qualification activities for facilities, utilities and process equipment, ensuring compliance and data integrity across the CAR‑T program.

You will collaborate with EMEA QA teams, work on deviations and CAPAs, and participate in inspections and process improvements to maintain international quality

Qualifications

• Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences.
• Awareness of quality; knowledge of cGMP regulations and FDA/EU guidance for cell therapy manufacturing.
• Affinity with computerized systems, data management in critical production assets.
• Strong communication skills and ability to work cross‑department in a changing environment.
• Thorough knowledge of Dutch and English, both written and spoken.
• Strong analytical thinking, risk assessment and communication skills.
• Collaboration and teamwork skills.

Responsibilities

• Review and approve qualification and requalification activities related to Facilities and Utilities and Process Equipment at Ghent facilities.
• Approve change controls and investigate deviations with potential impact on quality and compliance.
• Maintain liaison with different quality organizations and ensure data integrity.
• Review calibration rationales, calibration master forms and records; ensure data integrity and access reviews.
• Prepare for regulatory and customer inspections and act as QA qualification spokesperson.
• Approve qualification documents including deviations and corrective actions.

Skills

Analytical Thinking

Communication

Collaboration

Data Management

Quality Standards

GxP / QA

Education

Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences

Job description

Johnson & Johnson Innovative Medicines is recruiting a QA CAR-T Qualification Engineer for the CAR-T hub in Europe, supporting the Ghent area expansion. The role involves review and approval of qualification activities for facilities, utilities and process equipment, ensuring compliance and data integrity across the CAR‑T program.

You will collaborate with EMEA QA teams, work on deviations and CAPAs, and participate in inspections and process improvements to maintain international quality