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Maintenance Engineer

SIRE® Life Sciences 🧬

Leiden
Temporary
2-5 years experience
On-site

Key Skills

Maintenance Engineering
Asset Reliability
Maintainability Assessment
Preventive Maintenance
Corrective Maintenance
FMECA
GMP Compliance
Risk Assessment
P&ID Interpretation
Technical Documentation
CMMS
SAP PM
Project Coordination
Stakeholder Management
Change Control
Equipment Lifecycle Management

Job Description

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.

Core Responsibilities

Represent Maintenance in multidisciplinary projects and ensure maintenance, reliability, safety, and GMP requirements are incorporated from design through project execution. Prepare assets for operational handover by coordinating maintenance programs, risk actions, documentation, CMMS data, spare parts, service arrangements, and training.

Requirements

Requires HBO-level education or equivalent, preferably in a relevant engineering discipline, and at least two years of experience in a highly regulated environment. Candidates should understand GMP and maintenance engineering, interpret technical drawings, communicate effectively across teams, and take ownership of maintenance deliverables; SAP PM or another CMMS is an advantage.

About SIRE® Life Sciences 🧬

Industry: Biotechnology Research

Company size: 201-500 employees

SIRE® Life Sciences is the market-leading partner for Life Sciences consultancy, project management, and secondment services in the Netherlands. We specialize in connecting expert consultants and project managers with leading biotech, pharmaceutical, medical device, clinical research, and food technology organizations. Our services include: - Life Sciences recruitment & executive search - Interim management & secondment - SOW-based project outsourcing & delivery - RPO (Recruitment Process Outsourcing) - MSP workforce management & vendor-neutral solutions - GMP, GCP, GLP compliance staffing - Clinical research & regulatory affairs resourcing With 100,000+ professionals in our network and 25+ years of experience, SIRE® Life Sciences delivers measurable results for regulated organizations across the Netherlands and Europe. We work with pharma, biotech, medical device, CDMO, CRO, and food technology companies at every stage of the product lifecycle. What sets us apart: - Deep domain expertise in Life Sciences & regulated industries - Full compliance with GxP, ISO, WAADI, and Dutch labour law - Flexible engagement models: permanent, interim, project (SOW), and managed services - Proven delivery track record across Pharma, Biotech, MedTech & Food Science Based in Leiden Bio Science Park, Netherlands. www.sire-search.com

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