EMEA QA CAR-T Qualification Engineer

Johnson Johnson

Oost-Vlaanderen

Sur place

EUR 70 000 - 95 000

Plein temps

Il y a 3 jours

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Résumé du poste

Johnson & Johnson Innovative Medicines is recruiting a QA CAR-T Qualification Engineer for the Ghent CAR-T hub in Europe. The role involves reviewing qualification activities for facilities, utilities, and equipment, and ensuring deviations are properly investigated and CAPAs defined.

You will collaborate with E&PS, Engineering & Property Service, and other quality groups to safeguard product quality and compliance, while supporting inspections and continuous improvement in a fast-changing

Qualifications

Knowledge of cGMP and FDA/EU guidance for cell therapy manufacturing.
Familiar with computerized systems and data management in critical assets.
Strong communication skills and ability to work across departments.
Ability to navigate changing environments and regulatory expectations.
Proficiency in Dutch is preferred.

Responsabilités

Review and approve qualification and requalification activities for facilities and utilities and process equipment.
Approve change controls and ensure deviations are investigated with CAPAs.
Maintain compliance status of critical production assets and calibration records.
Prepare for regulatory and customer inspections and act as QA spokesperson.
Approve qualification documents including protocols, reports, and SOPs.
Participate in system/process improvement projects and stay updated on regulations.