GMP Utilities Engineer, Leiden, Zuid-Holland

The Company
Our client is a global organization operating in a highly regulated, technology-driven environment. The company focuses on developing advanced solutions that improve quality, reliability, and performance across critical applications. With a strong emphasis on innovation, sustainability, and operational excellence, the organization supports complex product development on a global scale.

Role Description
As a GMP Utilities Engineer, you will play a key role in ensuring the reliability and availability of technical utility systems supporting regulated production environments. You will support the Business System Owner (BSO) and take responsibility for managing HVAC, BMS, EMS, and Clean Utility systems, ensuring optimal performance in terms of reliability, quality, compliance, and cost.
This role requires strong technical expertise, a proactive mindset, and the ability to operate effectively within multidisciplinary teams in a fast-paced, regulated setting.

Responsibilities
- Manage and maintain HVAC, BMS, EMS, and Clean Utility systems to ensure reliable and compliant operations.
- Support long-term asset lifecycle planning, including CAPEX and investment planning.
- Support Management of Change (MoC) activities during design, commissioning, and qualification phases.
- Assess technical changes for impact, feasibility, and compliance based on data and risk analysis.
- Identify and execute required implementation activities within your area of expertise.
- Support technical and engineering projects, including system handover and operational readiness.
- Ensure compliance with applicable regulatory requirements and internal standards (e.g. GMP, EHS).

Requirements
- HBO working and thinking level with a technical background
- Minimum 2 years of experience in a highly regulated environment (e.g. pharmaceutical, biotech, medical devices)
- Strong knowledge of GMP systems and requirements
- Proven expertise in HVAC systems and associated control strategies (BMS)
- Experience with Clean Utilities (WFI/WDI) is a strong advantage
- Ability to read and interpret P&IDs
- Fluent in Dutch (mandatory) and good command of English

Other Information
Are you looking for a new challenge where your technical expertise makes a real impact? This opportunity offers a dynamic working environment, collaboration with experienced professionals, and the chance to contribute to critical operations within a regulated industry.

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