Car - t Operations Start - up Engineer

CAR-T 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.

Job Function: Supply Chain Manufacturing

Job Sub Function: Manufacturing Pharmaceutical Process Operations

Job Category: Professional

All Job Posting Locations: Zwijnaarde, Belgium

Job Description:

Are you inspired to make a significant difference in the life expectancy of our patients? 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.

This position will be supporting our newest manufacturing facility Tech Lane in the leading Biotechnology Hub of Ghent, Belgium. You will have the outstanding opportunity to work in a highly innovative and future oriented environment with the ability to profoundly impact on the trajectory of health of our patients.

Role and responsibilities:

The Start-Up Engineer 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 project team, you will collaborate with various other functions (such as engineering, quality assurance, quality control, health and safety, operations, planning, etc.) in a fast-paced project environment. Your responsibility is to ensure that our GMP manufacturing areas will be operationally ready for clinical and commercial production in a timely manner:

• You will dive deep into the entire manufacturing design process, developing in-depth expertise by supporting the implementation of new processes, advanced new technology equipment, optimized material flows, utilities, and manufacturing systems.
• You will be actively involved in the various project phases towards Operations Readiness (Design, Build, Qualification, Tech Transfer) to ensure all operational user requirements are captured and effectively implemented.
• You will work in a project-based manner with various functions and process development teams within the Johnson & Johnson and the Legend Biotech organization to successfully transfer CAR-T processes to a next level of advanced, cGMP-compliant manufacturing facilities.
• You will actively 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…), implementation of MAKE IT systems (MES, IDP, OSI-PI…), build project action plans, follow up on change controls, deviations or other project-related activities

Experience:

Minimum 5 years of relevant experience

Qualification & skills:

• You have a 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 like working together in a team setting towards common goals.
• You enjoy exploring new paths, enhancing 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.