QA CAR-T Qualification Engineer, EMEA (Ghent)

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

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Innovative Medicines is recruiting a QA CAR-T Qualification Engineer for the Ghent CAR-T hub in Europe. The role focuses on review and approval of qualification activities for facilities, utilities, and process equipment, ensuring deviations are thoroughly investigated and corrective actions defined.

You will collaborate with multiple quality and engineering teams and contribute to regulatory inspections, maintaining data integrity and QA expertise across the program.

Qualifications

• Master's degree in engineering with chemistry or analytical background or in pharmaceutical sciences.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products.
• Proficiency in Dutch and English, both written and spoken.

Responsibilities

• Review and approve qualification and requalification activities for Facilities & Utilities and Process Equipment at J&J/Legend Biotech facilities in Ghent.
• Collaborate with E&PS, Engineering, and Property Service to approve changes and investigate deviations.
• Ensure deviations are evaluated, investigated, and corrective/preventive actions implemented.
• Maintain data integrity through calibration records, master data setup, and calibration rationales.
• Prepare for regulatory and customer inspections and act as QA qualification spokesperson.
• Approve qualification documents including protocols, reports, and related corrective actions.
• Contribute to system/process improvement projects and stay updated on international regulations and industry practices.

Skills

Analytical thinking

Communication

Team collaboration

Dutch language

English language

Education

Master's degree in engineering with chemistry or pharmaceutical sciences

Job description

Johnson & Johnson Innovative Medicines is recruiting a QA CAR-T Qualification Engineer for the Ghent CAR-T hub in Europe. The role focuses on review and approval of qualification activities for facilities, utilities, and process equipment, ensuring deviations are thoroughly investigated and corrective actions defined.

You will collaborate with multiple quality and engineering teams and contribute to regulatory inspections, maintaining data integrity and QA expertise across the program.