CAR-T Start-Up Operations Engineer

Johnson & Johnson Innovative Medicine; Oost-Vlaanderen; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Open-ended contract

Competitive remuneration package

Résumé du poste

Johnson & Johnson Innovative Medicine in Belgium is seeking a Start-Up Engineer to join the Build Operations team, driving operations readiness for major CAR-T projects in Ghent. You will help deploy new equipment and advanced technologies across manufacturing areas, ensuring design, build, and qualification stages align with GMP standards.

You will collaborate with Ops, QA, IT, and external partners, managing documentation and supporting systems integration to enable safe, efficient production.

Qualifications

• 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.
• You see and seek opportunities, even when they are not immediately obvious.
• You embrace diversity, equity, and inclusion.

Responsabilités

• 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, SOPs, 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 within a multi-project expansion program.

Connaissances

Project management FPX

Cell processing

IT systems

Manufacturing automation

GMP knowledge

Formation

Master’s degree in engineering or scientific field

Outils

MES

SAP

Description du poste

Johnson & Johnson Innovative Medicine in Belgium is seeking a Start-Up Engineer to join the Build Operations team, driving operations readiness for major CAR-T projects in Ghent. You will help deploy new equipment and advanced technologies across manufacturing areas, ensuring design, build, and qualification stages align with GMP standards.

You will collaborate with Ops, QA, IT, and external partners, managing documentation and supporting systems integration to enable safe, efficient production.