QA CAR-T Qualification Engineer – EMEA (Ghent, Belgium)

Biopharma Careers

Oost-Vlaanderen

Hybrid

EUR 60,000 - 96,000

Full time

3 days ago

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Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being programs

Job summary

Johnson & Johnson Innovative Medicines is recruiting a QA CAR-T Qualification Engineer for the Ghent CAR-T hub in Belgium. The role ensures qualification of facilities, utilities, and process equipment, and manages data integrity and calibration records within a GMP-compliant framework.

The ideal candidate holds a master’s degree in engineering or pharma sciences, is fluent in English and Dutch, and can work cross-functionally to prepare for inspections and continuous improvements in a

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
: Familiarity with computerized systems and data management
: Strong communication and cross-functional collaboration
: Dutch and English proficiency

Responsibilities

Review and approve qualification activities for facilities, utilities and process equipment.
Approve calibration rationales, master documents and data integrity deliverables.
Support regulatory inspections and QA qualification activities.
Collaborate with Engineering & Property Service on change controls and deviations.
Maintain current knowledge of international regulations and QA processes.