Continued Process Verification Engineer

Continued Process Verification Engineer | CAR-T EMEA

Location: Gent Obelisc, Gent Tech Lane (On-site, occasional opportunity to work hybrid)

Duration: 6 months

Hours: 40 hours per week

Imagine your next project supporting a unique, ground-breaking CAR-T cell therapy program in Europe, working with an innovative treatment that uses the power of the patient’s own immune system to eliminate cancer cells where other therapies have failed.

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. Patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results. Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize (CAR) T-cell therapy. This partnership is designed to combine the strengths and expertise of two companies to deliver on the promise of a CAR T platform for immunotherapy and investigational treatment. To support the CAR-T program in EMEA, we are working with great enthusiasm on expanding our capacity. The CPV engineer is part of the MSAT team and closely connected to the Tech Transfer workstream.

roles and responsibilities

• Support CPV Report Generation: Assist two lead engineers in gathering data, drafting sections, and routing the Annual Stage 3 CPV report for approval.

• Data Extraction & Structuring: Pull manufacturing and analytical data from electronic systems (MES, LIMS, SAP) for key CAR-T metrics like cell viability, harvest yield, and transduction efficiency.

• Statistical Trending: Perform routine data entry and initial statistical analysis (using JMP or Minitab) to monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

• Identify Process Drift: Flag initial Out-of-Trend (OOT) data or process variations to the lead CPV engineers for deeper investigation.

• Cross-Functional Coordination: Partner with Quality Assurance (QA) and MSAT specialists to track down missing batch documentation and deviation updates.

• Map the As-Is Process: Baseline the current state of particle monitoring across the CAR-T manufacturing workflow. Detail existing sampling points, inspection methods, and data flows.

• Trend & Track Deviations: Monitor historical and real-time visible and sub-visible particulate data. Identify process drift, investigate particle-related deviations, and pinpoint root causes.

• Design the To-Be Framework: Architect the future-state governance model to improve particle mitigation. Define enhanced monitoring strategies, stricter alert/action limits, and optimized handling protocols.

• Lead the Particle Board: Present technical data, trending reports, risk assessments, and proposed "to-be" frameworks directly to the cross-functional Particle Governance Board for strategic alignment.

• Review and optimize particle monitoring processes that are currently scattered to make them LEAN, including improving and rewriting procedures.

how to succeed

• 2-3 years of relevant experience is required.

• Strong technical writing skills.

• Advanced therapeutics experience is ideal.

• Experience with GMP and change control management.

• Proficiency in using statistical analysis software such as JMP or Minitab.

• Familiarity with extracting data from electronic systems like MES, LIMS, and SAP.

• Mandatory fluency in English; Dutch is nice to have.

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months

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 or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.