Maintenance Engineer, Leiden, Zuid-Holland

The Company
A leading biopharmaceutical organization dedicated to developing and manufacturing cutting-edge biologic medicines. With a strong focus on quality and innovation, the company strives to deliver advanced therapies that enhance global health and improve patient outcomes.

Role Description
As a Maintenance Engineer Projects, you act as the link between Maintenance and Engineering during new?build, refurbishment, and modification projects. You ensure that installations are designed and delivered with full attention to reliability, maintainability, and GMP compliance. You join projects from the earliest stages and guide them until complete handover to operational teams.

Responsibilities
- Provide maintenance input in project teams from the initial design phase.
- Review URS and technical designs and define maintenance requirements.
- Advise Engineering and contractors on maintainability and compliance.
- Develop and validate maintenance plans and assign execution owners.
- Lead FMECA workshops and ensure follow?up of mitigation actions.
- Verify as?built documentation (P&IDs, schematics, CMMS data) and prepare handover packages.
- Coordinate maintenance readiness including checklists, training, and transfer to operations.
- Drive change requests, decommissioning activities, and report maintenance risks and KPIs.
 
Requirements
- HBO level with a technical background.
- Minimum of 2 years of experience in a highly regulated (pharmaceutical/GMP) environment.
- Strong knowledge of GMP systems and requirements.
- Ability to read and interpret P&IDs.
- Strong analytical and problem?solving skills.
- Good communication skills in Dutch and English.

Other Information
Are you interested and do you want to apply for this role? Please fill out your application via the apply button below.

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