QA Project Engineer MES, CAR-T Europe

Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson. QA Project Engineer MES, CAR-T Europe.

Location: Ghent (On site).

Duration of the contract: Until 30 June 2027.

Hours per week: 40 per week | Contract: Fixed-term Employee Payroll only (No B2B / No Freelancers). Imagine your next project helping to shape how digital quality supports life-saving cancer treatments. CAR-T therapy uses a patient’s own engineered T-cells to target and eliminate cancer cells. Our Ghent manufacturing sites support this innovative treatment across EMEA, while cryopreservation activities and Quality Control laboratory testing take place in Beerse.

As part of the QA MES team, you will oversee assigned QA deliverables from planning to completion. Join a growing international team and help shape how digital quality supports CAR-T manufacturing and patient delivery.

Roles and responsibilities: Your core focus is reviewing MBR verification documentation for electronic master batch records developed by MES technical experts from routine user requirements. You will collaborate with MES technical experts, QA Operations, Operations, IT, and project teams to support timely, compliant delivery.

This will involve: Provide QA oversight of MBR verification activities in line with approved procedures, timelines and priorities. Review MBR checklists, Design Documentation Specifications, testing strategies and test protocols for electronic master batch records created or updated from routine user requirements. Review executed verification protocols and supporting evidence, document comments and follow them through resolution. Review traceability matrices, PQ documentation, project quality plans, summary reports and go-live documentation.

Support quality and data-integrity oversight of PAS-X master data, electronic batch records and other MES elements through documentation review. Confirm that reviewed deliverables meet GMP, data-integrity and internal procedural requirements. Identify and follow up risks, deviations, test observations and actions. Contribute to continuous improvement across QA MES. Keep stakeholders aligned through clear updates and timely escalation. Maintain complete, accurate and inspection-ready documentation.

How to succeed: We are looking for a QA professional with strong analytical and decision-making skills who can work independently and build strong cross-functional relationships.

You will also bring: A bachelor’s or master’s degree in bio-engineering, pharmacy or another relevant technical or scientific field. At least three years of cross-functional pharmaceutical industry experience (No maximum experience limit). Sound knowledge of cGMP requirements and relevant pharmaceutical regulations. Hands-on experience with master batch records and QA in a GMP production environment. Experience reviewing MBR verification or qualification documentation is strongly preferred.

MES production experience is a strong advantage; PAS-X, Opstracker experience is particularly valuable. Strong analytical, communication and decision-making skills, with a practical, solution-oriented mindset. Ability to work independently and build strong cross-functional relationships.

Benefits: This role offers a very competitive hourly rate. This contract will run until 30 June 2027.

You are welcome here: Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. About Johnson & Johnson Innovative Medicine: Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Application process: We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.