QA CAR-T Qualification Engineer – EMEA

NCSL International

Oost-Vlaanderen

Hybrid

EUR 60,000 - 96,000

Full time

4 days ago

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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 related to Facilities & Utilities and Process Equipment at J&J/Legend Biotech facilities, ensuring compliance and data integrity.

You will collaborate with E&PS and Engineering & Property Service, support regulatory inspections, and act as QA qualification spokesperson to uphold quality standards across the CAR-T program in Europe.

Qualifications

Master's degree in engineering with chemistry or analytical background.
Knowledge of cGMP and FDA/EU guidance related to manufacturing of cell therapy products.
Affinity with computerized systems and data management.
Excellent Dutch and English communication, both written and spoken.
Strong analytical thinking, risk assessment and communication skills.
Team-oriented with cross-functional collaboration.

Responsibilities

Review and approve qualification activities for facilities, utilities and process equipment.
Evaluate deviations and ensure corrective actions are defined and implemented.
Collaborate with E&PS and Engineering/Property Service on changes.
Manage data integrity deliverables and calibration records.
Support regulatory inspections and act as QA qualification spokesperson.
Participate in system/process improvement and maintain knowledge of regulations.