Maintenance Engineer in Leiden

As a Maintenance Engineer Projects, you act as the key link between Maintenance and Engineering, ensuring that maintenance and reliability requirements are embedded in technical projects from the earliest design stages through final handover. You will support new-build, refurbishment, and modification projects involving both utilities and production equipment. By contributing to User Requirements Specifications (URS), design reviews, and project execution, you ensure that new or modified installations are maintainable, reliable, safe, GMP-compliant, and operationally ready. You will also coordinate the transition from Engineering to Maintenance, ensuring that maintenance strategies, spare parts, technical documentation, CMMS data, training, and other handover requirements are in place before assets enter operation. Responsibilities

Represent the Maintenance function within multidisciplinary project teams and provide maintenance input from the early project and design phases. Review URS and engineering designs and translate maintenance needs into clear technical requirements for Engineering teams, contractors, and other stakeholders. Serve as the main point of contact between Maintenance and project teams, coordinating actions and keeping relevant stakeholders informed of progress, risks, and requirements. Assess designs for maintainability, reliability, safety, and compliance, and verify that agreed requirements are implemented. Develop and validate preventive and corrective maintenance programs, including initiating, reviewing, approving, and assigning maintenance activities. Lead or facilitate FMECA (Failure Mode, Effects and Criticality Analysis) sessions, define risk mitigation measures, and monitor completion of resulting actions. Verify as-built technical documentation, including P&IDs, schematics, equipment information, and CMMS records, to ensure documentation is accurate and ready for handover. Prepare installations for operational handover by developing readiness checklists, providing maintenance recommendations, and coordinating training and knowledge transfer to operational teams. Ensure appropriate arrangements are established for spare parts, service agreements and SLAs, where applicable. Coordinate maintenance-related aspects of change controls, modifications, and equipment decommissioning, including risk assessments. Monitor and communicate maintenance risks, project progress, actions, and relevant KPIs to stakeholders and management. Support the availability and long-term reliability of pharmaceutical production and utility assets through a proactive, lifecycle-focused maintenance approach. Requirements

HBO-level education or equivalent working and thinking level, preferably in Mechanical Engineering, Electrical Engineering, Maintenance Engineering, or another relevant technical discipline. At least 2 years of professional experience in a highly regulated environment, preferably within the pharmaceutical, biotechnology, or GMP-regulated industry. Good knowledge of GMP requirements and quality systems relevant to pharmaceutical manufacturing and maintenance. Strong ability to read and interpret P&IDs and other technical drawings and documentation. Understanding of maintenance engineering principles, particularly asset reliability, maintainability, preventive maintenance, and equipment lifecycle management. Strong analytical and problem-solving capabilities with excellent attention to detail. Ability to work effectively across Maintenance, Engineering, Operations, Quality, and external contractors. Strong stakeholder management and communication skills, including the ability to coordinate actions and independently drive issues to resolution. Comfortable working in a dynamic project environment and managing technical changes while maintaining a strong focus on quality and compliance. Good command of English, both written and spoken. Experience with SAP PM or another CMMS is considered an advantage. Proactive, accountable, and results-oriented working style with the ability to work independently and take ownership of maintenance deliverables.

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