QA CAR‑T Qualification Engineer, EMEA

7555-Janssen Pharmaceutica NV Legal Entity; Oost-Vlaanderen; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus potential

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

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 Ghent/Beerse, ensuring quality and compliance.

You will collaborate with E&PS, Engineering & Property Service, and QA organizations; prepare for inspections and maintain regulatory alignment, data integrity, and documentation completeness across the CAR‑T program.

Qualifications

• External master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences; awareness of quality; have knowledge of cGMP and FDA/EU guidance related to manufacturing of cell therapy products.
• Affinity with computerized systems, System parameter configurations and data management in critical production assets; demonstrate strong communication and cross-department collaboration.
• Thorough knowledge of Dutch and English, both orally and in writing.

Responsibilities

• Will work with E&PS to guard qualification status of critical production assets by ensuring system aspects are identified, qualified and controlled; deviations with potential impact are evaluated and acted upon.
• Collaborate with Engineering & Property Service to approve change controls and ensure corrective actions are defined and implemented.
• Build strong connections with different quality organizations.
• Manage compliance status of critical production assets with procedures, calibration, master data, and data integrity deliverables.
• Participate in regulatory and customer inspections and act as QA qualification spokesperson.
• Approve qualification documents including discrepancies and corrective actions.
• Participate in system and process improvement projects and maintain knowledge of regulations and industry practices.

Skills

Analytical Reasoning

Coaching

Data Savvy

Quality Standards

Quality Systems Documentation

Engineering

Process Improvements

Supply Planning

Documentation Management

Education

Master's degree in engineering or 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 Ghent/Beerse, ensuring quality and compliance.

You will collaborate with E&PS, Engineering & Property Service, and QA organizations; prepare for inspections and maintain regulatory alignment, data integrity, and documentation completeness across the CAR‑T program.