CAR-T Operations Startup Engineer: Build & Scale GMP Manufacturing

Johnson & Johnson Innovation; Zwijnaarde; In loco; EUR 60.000 - 96.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Descrizione del lavoro

Johnson & Johnson is seeking a Start-Up Engineer to join the Build Operations team in Ghent, Belgium. You will help ensure operational readiness for major CAR-T projects, coordinate with cross-functional teams and deploy new equipment and technologies.

The role focuses on expanding facilities, enabling production, and maintaining GMP standards across design, build, qualification, and tech transfer processes. A strong engineering background and experience in manufacturing automation are essential.

Competenze

• 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.

Mansioni

• 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

Conoscenze

Agile Manufacturing

Analytics Dashboards

Business Behavior

Communication

Problem Solving

Process Optimization

Project Administration

Team Collaboration

Formazione

Master’s degree in Engineering or Scientific field

Strumenti

MES

SAP

Descrizione del lavoro

Johnson & Johnson is seeking a Start-Up Engineer to join the Build Operations team in Ghent, Belgium. You will help ensure operational readiness for major CAR-T projects, coordinate with cross-functional teams and deploy new equipment and technologies.

The role focuses on expanding facilities, enabling production, and maintaining GMP standards across design, build, qualification, and tech transfer processes. A strong engineering background and experience in manufacturing automation are essential.