Senior QA Engineer, MES – CAR-T Europe

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Gent, East Flanders, Belgium

Job Description: About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

As a Senior QA Engineer, MES – CAR-T Europe you will:

Join Johnson & Johnson Innovative Medicine as a Senior QA Engineer MES, and help ensure the compliant lifecycle of electronic master batch records for our CAR-T manufacturing hub in Ghent and for the cryo center in Beerse. In this role, you will provide quality oversight and review verification documentation for electronic master batch records created or updated based on user requirements from the routine organization. CAR-T therapy uses a patient’s own engineered T cells to target and eliminate cancer cells. Our Ghent manufacturing sites support delivery of this innovative treatment across EMEA, with cryopreservation activities and Quality Control laboratory testing performed in Beerse. As part of the QA MES team, you will manage assigned quality deliverables from planning through completion. You will work closely with MES technical experts, QA Operations, Operations, IT and project teams to support timely, compliant delivery and maintain inspection‑ready documentation. Join the QA MES team and help shape how digital quality enables CAR‑T manufacturing and reliable patient delivery.

The responsibilities and the impact YOU will have:

• Act as backup to the QA MES Manager, supporting the broader scope of QA MES activities and taking decisions, as needed, on strategic matters, key projects, priorities and escalations.
• Provide QA oversight of MES MBR verification activities in accordance with approved procedures, project timelines and business priorities.
• Represent QA MES in project core teams, contribute to strategy determinations and participate in key project workshops.
• Review and approve, as applicable, quality project and execution plans, MBR checklists, design documentation specifications, test plans and testing strategies, test protocols, traceability matrices, performance qualification documentation, summary reports and go‑live documentation.
• Review executed test and PQ protocols and supporting evidence, document observations and ensure timely resolution.
• Monitor risks, deviations, test observations and actions, ensuring deliverables meet GMP, data integrity and internal procedural requirements.
• Approve master data, electronic batch records and other MES elements in the MES system in accordance with approved procedures.
• Lead MES audit and inspection readiness, act as the QA spokesperson, and support the investigation and follow‑up of audit observations.
• Represent the site within the global J&J MES QA network and ensure alignment between global procedures and local requirements.
• Actively participate in quality risk assessments, including FMEAs, risk mitigation activities, and residual risk evaluations.
• Review MES related non‑conformances, support root cause investigations, and CAPA proposals.
• Act as QA approver for MES MBR verification procedures and MES specific change controls, including plans, amendments and implementation evidence.
• Maintain complete, accurate and inspection‑ready documentation, and keep stakeholders aligned through clear communication and timely escalation.
• Support QA MES team effectiveness through workload planning, prioritization, onboarding and training oversight.
• Drive continuous improvement by contributing to the QA MES roadmap and supporting implementation of improvement initiatives.

We would love to hear from YOU, if you have th