Senior QA Engineer, MES – CAR-T (Europe)

Johnson Johnson; Gent; Hybrid; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Competitive compensation

Annual bonus

Generous vacation

Parental leave

Well-being programs

Job summary

Johnson & Johnson is seeking a Senior QA Engineer MES for CAR-T Europe in Ghent/Beerse. You will ensure compliant lifecycle management of electronic master batch records and support CAR-T manufacturing with QA oversight, MES expertise and cross-functional collaboration.

The role requires a strong background in GMP, MES systems and change control, with the ability to drive inspection readiness and risk management across sites within the EMEA region.

Qualifications

• Bachelor's or master's in bioengineering, pharmacy or a related technical field.
• At least five years of cross-functional pharma experience.
• Solid knowledge of cGMP requirements and regulations.
• Hands-on experience with master batch records and GMP QA.
• Experience with MES in manufacturing; PAS-X or Opstracker is valuable.

Responsibilities

• Provide QA oversight of MES MBR verification activities per procedures and timelines.
• Review and approve quality project plans, MBR checklists, test plans and validation docs.
• Lead MES audit readiness and act as QA spokesperson for audit findings.
• Collaborate with MES, QA Operations, IT and project teams to ensure compliant delivery.
• Maintain inspection-ready documentation and escalate issues in a timely manner.

Skills

Quality Engineering

GxP Compliance

cGMP Knowledge

Data Analysis

Regulatory Awareness

Education

Bachelor or Master in bioengineering/pharmacy or related

Tools

PAS-X

Opstracker

Job description

Johnson & Johnson is seeking a Senior QA Engineer MES for CAR-T Europe in Ghent/Beerse. You will ensure compliant lifecycle management of electronic master batch records and support CAR-T manufacturing with QA oversight, MES expertise and cross-functional collaboration.

The role requires a strong background in GMP, MES systems and change control, with the ability to drive inspection readiness and risk management across sites within the EMEA region.