Maintenance Specialist Projects, Leiden, Zuid-Holland

The Company
The client is part of the global pharmaceutical company. The facility is focused on the development and manufacturing of biologic medicines, particularly in the fields of immunology, oncology, and infectious diseases. They specialize in producing large-scale biologic drugs, which are typically made from living cells and are used to treat complex diseases. 

Role Description
As a Maintenance Specialist Projects, you act as the essential link between the Maintenance and Engineering departments. You ensure that maintenance and reliability requirements are built into new construction, redevelopment, and modification projects from the earliest design phase. Your involvement guarantees that delivered systems are operationally ready, compliant with GMP standards, and optimized for long-term performance. By participating early in drafting URS documents and reviewing designs, you secure seamless handovers from Engineering to Maintenance with full attention to maintainability, reliability, safety, SLA’s, and spare parts strategy. You function as the central point of contact (SPOC), ensuring that all as-built documentation, drawings, and system files are validated and ready before final approval. Your scope includes both utility systems and specialized production equipment. 

Responsibilities

• Representing Maintenance in project teams: participate early, review URS and design documents, and assign maintenance requirements to project stakeholders.
• Acting as the connection between the maintenance organization and project teams, ensuring timely execution of actions and clear communication among all parties.
• Advising on design choices to ensure maintainability and verify compliance by engineering teams and contractors.
• Leading FMECA sessions: facilitating workshops, defining mitigation actions, and monitoring follow-up with responsible owners.
• Creating and managing maintenance programs: initiate, assess, approve, and assign responsibility for execution.
• Ensuring proper as-built documentation: verifying P&ID’s, technical schematics, and CMMS master data to prepare for handover.
• Assessing maintenance readiness: preparing checklists, providing handover recommendations, and coordinating training for operational teams.
• Managing change requests and decommissioning activities: leading risk assessments and report on maintenance-related risks, progress, and KPIs to management. 

Requirements

• Technical background with at least a bachelor-level (HBO) working and thinking capability.
• Minimum of 2 years’ experience in a highly regulated (preferably pharmaceutical/GMP) environment.
• Proven understanding of GMP systems and compliance requirements.
• Strong ability to read and interpret P&ID’s.
• Excellent communication skills, including proficiency in English.
• Strong analytical and problem-solving skills with high attention to detail.
• Experience with SAP PM or another CMMS is an advantage. 

Other information
Apply to our vacancy for more information. Looking forward to getting in touch! 

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