EMEA CAR-T QA Qualification Engineer

Johnson & Johnson Co.; Gent; On-site; EUR 60,000 - 96,000; Full time

Job summary

Johnson & Johnson in Ghent, Belgium, is recruiting a QA CAR-T Qualification Engineer for the CAR‑T hub in Europe. You will review and approve qualification activities for Facilities & Utilities and Process Equipment at the Ghent/J&J Legend Biotech facilities, ensuring data integrity and compliant records.

You will collaborate across Quality, E&PS and Operations, support inspections, and drive continuous improvement in a dynamic cell-therapy environment.

Qualifications

• Master’s degree in engineering with chemistry or analytical background, or pharmaceutical sciences.
• Knowledge of cGMP and FDA/EU guidance for cell therapy manufacturing.
• Affinity with computerized systems and data management in critical production assets.
• Strong cross‑departmental communication and teamwork.

Responsibilities

• Review and approve qualification activities for facilities and utilities and process equipment.
• Approve deviations and implement corrective and preventive actions.
• Maintain data integrity deliverables and calibration records.
• Collaborate with QA, E&PS, and operations to ensure compliance.
• Prepare for regulatory and customer inspections and act as QA spokesperson.
• Participate in system and process improvement projects.
• Maintain knowledge of international regulations and industry practices.

Skills

Analytical thinking

Communication skills

Teamwork

Risk assessment

Data management

Education

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

Job description

Johnson & Johnson in Ghent, Belgium, is recruiting a QA CAR-T Qualification Engineer for the CAR‑T hub in Europe. You will review and approve qualification activities for Facilities & Utilities and Process Equipment at the Ghent/J&J Legend Biotech facilities, ensuring data integrity and compliant records.

You will collaborate across Quality, E&PS and Operations, support inspections, and drive continuous improvement in a dynamic cell-therapy environment.