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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 the following essential requirements:

• A bachelor's or master's degree in bioengineering, pharmacy or another relevant technical or scientific discipline.
• At least five years of cross-functional experience in the pharmaceutical industry.
• Sound knowledge of cGMP requirements and applicable pharmaceutical regulations.
• Hands-on experience with master batch records and quality assurance in a GMP manufacturing environment.
• Experience reviewing MBR verification or qualification documentation is strongly preferred.
• Experience with MES in a manufacturing environment is a strong advantage; knowledge of PAS-X or Opstracker is particularly valuable.
• Strong analytical, communication and decision-making skills, combined with a practical and solution-oriented mindset.
• The ability to work independently, manage priorities and build effective cross-functional relationships.

Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

#SCQuality

Required Skills:

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

The anticipated base pay range for this position is:

€72,500.00 - €115,230.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.