CAR-T Ghent Startup Operations Engineer

7555-Janssen Pharmaceutica NV Legal Entity; Zwijnaarde; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being programs

Résumé du poste

Johnson & Johnson in Belgium is seeking a Start-Up Engineer for the Build Operations team in Ghent. You will ensure operational readiness for major CAR‑T projects, including facility expansions and deployment of new equipment to support commercial production.

You will collaborate across Ops, QA, QC, MSAT, IT and external partners to drive process optimization, documentation development, and systems integration within an expanding manufacturing environment.

Qualifications

• Master’s degree in engineering or a scientific field.
• Experience in project management, FPX, cell processing, IT systems, and advanced manufacturing automation technologies.
• Knowledge of GMP regulatory framework (cGMP, ICH, Eudralex Vol 4, ATMP).
• You embrace diversity, inclusion, integrity, and sustainability in procedures and changing situations.

Responsabilités

• Act as a key member of the expansion project team in a fast-paced environment.
• Ensure GMP areas are operationally ready for commercial production across project phases (Design, Build, Qualification, Tech Transfer).
• Deep dive into manufacturing design and support implementation of new processes and systems.
• Develop and review documentation (User Requirements, SOPs, Work Instructions, Master Batch Records, Protocols).
• Support MES, SAP, and other systems to enable efficiency and compliance.
• Engage in audits and drive cross-functional collaboration across Ops, QA, QC, MSAT, IT and external partners.

Connaissances

GMP knowledge

Project management

Technical credibility

Formation

Master’s degree in Engineering or related field

Outils

MES

SAP

Description du poste

Johnson & Johnson in Belgium is seeking a Start-Up Engineer for the Build Operations team in Ghent. You will ensure operational readiness for major CAR‑T projects, including facility expansions and deployment of new equipment to support commercial production.

You will collaborate across Ops, QA, QC, MSAT, IT and external partners to drive process optimization, documentation development, and systems integration within an expanding manufacturing environment.