Engineer FM engineering

Leiden Bio Science Park; Leiden; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Employee learning & development

Job summary

Leiden Bio Science Park is seeking an FM Engineer to ensure safe, compliant operation of facility infrastructure in a GMP-regulated pharma setting. You will lead preventive maintenance, drive reliability improvements, and coordinate with Operations, Quality, and Engineering teams.

The role involves risk-based asset prioritization, lifecycle planning, and supplier management, with emphasis on data integrity and continuous improvement within SAP/CMMS systems.

Qualifications

• Bachelor's degree in Engineering, Facilities Management, Asset Management, or a related technical discipline.
• Minimum 2+ years of experience in facilities engineering, maintenance engineering, utilities, asset management, or reliability engineering.
• Experience in GMP-regulated environments and with SAP or CMMS is preferred.
• Strong knowledge of GMP, EHS&S, CAPA, Change Control, and quality systems.
• Demonstrates an understanding of AI concepts and prompt engineering practices.

Responsibilities

• Ensure GMP, EHS&S, engineering, and company procedures are followed.
• Act as SME for audits, inspections, CAPAs, change controls, and quality events.
• Lead preventive and predictive maintenance programs and lifecycle management.
• Manage external service providers and collaborate with cross-functional teams.
• Develop asset condition assessments and long-term replacement planning.
• Support investigations, CAPAs, and inspection readiness.

Job description

The Engineer FM is responsible for ensuring the safe, compliant, reliable, and cost-effective operation of facility infrastructure, building assets, and associated utility systems across the Leiden Bio site. The role provides technical leadership in asset maintenance, reliability improvement, regulatory compliance, contractor management, and continuous improvement initiatives. You will be part of vibrant FM department and a new FM engineering sub-team, supporting the FM department to increase our footprint and ownership on site an accelerate on bringing our knowledge and our facility to advanced control. Based on current business need, you will work on one of the three disciplines, depending on the best match based on experience & knowledge and growth potential: (1) Black utilities drain & sewer system and contamination avoidance (2) FM engineering structural improvements, project initiation, and building assets governance (3) FM engineering hard services reliability program and data integrity implementation. You will work within a highly regulated pharma environment global regulatory requirements, quality management systems, and J&J internal standards. Within your specialism you will keep maintaining broad collaboration across Operations, Quality, EHS&S, Engineering, Maintenance, and Facilities Management. As an FM engineer you acts as a Subject Matter Expert (SME), drives preventive and predictive maintenance strategies, supports investigations and CAPAs, initiates improvement projects, and contributes to inspection readiness and operational excellence.

Essential CORE Job Duties and Responsibilities

Compliance, Quality & Safety

• To the highest standards ( GMP, EHS&S, engineering , and company procedures.)
• Technical SME responsible for audits, inspections, investigations, CAPAs, change controls, and quality events.

FM Asset Management & Maintenance

• Proactive, preventative, ensuring business continuity and root cause problem solving
• Support lifecycle management, replacement planning, and risk-based asset prioritization.
• Manage external service providers and specialist contractors.
• Collaborate with Operations, Engineering, Quality, Maintenance, and Project Delivery teams.
• Maintain site-level customer relationships with peers from Operations, Quality, Maintenance and Engineering, understand their expectations and translate them into business service solutions
• Well organized on knowledge capturing, standard work and documentation.

Specialist track 1: Utilities, Drains & Sewer Systems - Key Accountabilities

• Act as SME for sanitary drains, process drains, sewer systems, interceptors, backflow prevention devices, and wastewater infrastructure.
• Develop maintenance strategies and inspection programs for drainage and sewer assets.
• Manage contamination-control risks associated with wastewater and drainage systems.

Specialist Track 2: FM Building Assets & Project Initiation - Key Accountabilities

• Act as SME for Office building assets including floors, walls, ceilings, roofs, doors, windows, elevators, access systems, lifting equipment, and related infrastructure.
• Highly collaborate with the Hard services clean room manufacturing team for project initiation.
• Own asset condition assessments and long-term replacement planning.
• Identify facility deficiencies and initiate corrective projects.

Specialist Track 3: Reliability & Data Integrity - Key Accountabilities

• Develop reliability programs for FM assets and black utility systems.
• Lead asset criticality assessments and maintenance optimization initiatives.
• Improve data quality and technical integrity within SAP, CMMS, and asset databases.

EDUCATION, EXPERIENCE & CERTIFICATIONS

• Bachelor's degree in Engineering, Facilities Management, Asset Management, or a related technical discipline.
• Minimum 2+ years of experience in facilities engineering, maintenance engineering, utilities, asset management, or reliability engineering.
• Experience within a GMP-regulated or highly regulated environment preferred.
• Experience with SAP or CMMS systems. (Preferred)
• Experience managing contractors and technical service providers. (Preferred)
• Knowledge of GMP, EHS&S, CAPA, Change Control, and quality systems. (Preferred)
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity

OTHER KNOWLEDGE, SKILL, ABILITY AND EXPERIENCE REQUIRED.

• Strong focus and technical skills on EHS&S and GMP Quality
• Experience with short term and long term root cause problem solving
• Strong analytical skills, critical thinking, details matter
• Initiate continuous improvement of processes and working methods
• Technical writing knowledge
• Good interpersonal skills to work with many different disciplines/nationalities/levels
• Proficient English, Dutch preferred
• Availability to work in a strong demanding and fast changing environment

Required Skills

• Facility Engineering, Facility Management

Preferred Skills

• Agility Jumps
• Calibration Procedures
• Collaboration
• Data Savvy
• Equipment Maintenance
• Execution Focus
• Facilities Construction
• Lean Supply Chain Management
• Personal Development
• Plant Operations
• Proactive Behavior
• Project Recovery
• Project Schedule
• Quality Assurance (QA)
• Science, Technology, Engineering, and Math (STEM) Application
• Technologically Savvy