Car-T Operations Start-Up Engineer

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.

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking, innovative technology provides hopeful prospects for patients where other therapies have failed or fail to provide adequate results.

We are currently in the project phase of a new innovative CAR-T project. A growing team of passionate talent is building the new sites in Ghent, developing, and advancing all tools, processes and procedures that ensure a highly reliable, safe, and efficient production process. J&J entered this platform in a global, strategic partnership with Legend Biotech.

As a Start-Up Engineer, you are part of the Build Operations team, where you will be instrumental in ensuring operational readiness for major projects within the Car-T Ghent organization, including facility expansions and the deployment of new equipment or other future-proof advanced technologies in our existing manufacturing areas.

As a key member of our expansion project team, you will collaborate with various other functions in a fast-paced project environment. Your responsibility is to ensure that our GMP manufacturing areas will be operationally ready for commercial production in a timely manner:

• →Act as project support to ensure all operational user requirements are captured and effectively implemented throughout the various project phases towards Operations Readiness (Design, Build, Qualification, Tech Transfer)

• →Deep dive into the entire manufacturing design process, developing in-depth expertise by supporting the implementation of new processes, optimizing material flows, utilities, and manufacturing systems

• →Contribute to the timely development and review of documentation (User Requirement Specifications for new technologies or equipment, Standard Operation Procedure, Work Instructions, Master Batch Records, Qualification Protocols…)

• →Support systems and digital integration (MES, SAP, etc.), ensuring systems enable operational efficiency and compliance

• →Ensure quality and compliance, including change controls, inspection readiness, and acting as spokesperson during audits

• →Drive cross-functional collaboration and stakeholder alignment (Ops, QA, QC, MSAT, EHS, IT, Planning, external partners) within a multi-project expansion program

Minimum 3 years of relevant experience

• Master’s degree, preferably in an engineering or scientific field (Engineering, Bioscience Engineering, Biochemistry, Pharmacy, …)

• Experience in project management (FPX), cell processing, IT systems, advanced manufacturing automation technologies

• Knowledge of the GMP regulatory framework (including cGMP, ICH, Eudralex Vol 4, ATMP, etc.) is considered a valuable asset

• You enjoy exploring new paths, leveraging your knowledge and experience, while continually expanding your skills to discover innovative solutions for emerging challenges.

• You see and seek opportunities, even when they are not immediately obvious.

• You embrace diversity, equity, and inclusion.

• You maintain high standards of integrity, respect, and sustainability.

• You can deal with procedures and guidelines that require strict application, and with changing situations where not everything is clear yet.

• The opportunity to participate in a progressive treatment that gives hope to patients in need

• The ability to help shape a new venture from the start

• An innovative and dynamic working environment

• Opportunities to continue developing and growing within a strong and expanding organization

• An open-ended contract with a competitive remuneration package