Company
A leading biopharmaceutical manufacturing organization is expanding its on-site engineering team in the Netherlands. The site operates in a highly regulated environment and delivers complex, life-impacting products, with a strong focus on safety, quality, and continuous improvement.
Job Description
The Engineering Project Lead (Utilities & Facilities) will manage small to medium-sized engineering capital projects across equipment, facilities, and utilities within a biopharmaceutical manufacturing environment. From feasibility and business-case development through design, construction, and handover, the role will drive technical execution while ensuring safety, quality, budget, and schedule expectations are met.
Responsibilities
- Lead end-to-end delivery of engineering projects related to equipment, facilities, and utilities, with a strong emphasis on HVAC and mechanical/technical scope.
- Run feasibility assessments, define scope, and translate business needs into clear project plans and technical requirements.
- Coordinate multidisciplinary teams (engineering, operations, quality, validation, EHS, and external partners) to deliver project milestones.
- Oversee on-site execution activities during construction and implementation, ensuring safe and compliant working practices.
- Manage project risks, track progress, and clearly communicate status, decisions, and escalations to stakeholders and leadership.
- Ensure alignment with applicable industry and internal standards, including regulated manufacturing expectations.
- Support validation and qualification activities across the lifecycle (e.g., FAT/SAT, IQ/OQ/PQ) and ensure robust handover to operations.
- Capture lessons learned and drive continuous improvement in project delivery methods and ways of working.
Requirements
- BSc or MSc in Engineering or a related technical discipline.
- At least 5 years of technical project management experience in regulated industries (e.g., pharma, biotech, medical devices, chemical, food, semiconductor).
- Strong experience with utilities/facilities projects, ideally including HVAC and mechanical systems.
- Solid understanding of cGMP manufacturing and regulated project execution.
- Familiarity with validation approaches and project delivery in a regulated environment (e.g., GAMP concepts, ASTM E2500; FAT/SAT; IQ/OQ/PQ).
- Confident stakeholder management skills with the ability to lead cross-functional teams and navigate challenging discussions.
- Working knowledge of project planning tools (e.g., Microsoft Project); PM certification (CAPM/PMP/PRINCE2) is a plus.
Other Information
This is an on-site position based in Hoofddorp, the Netherlands, supporting a busy manufacturing environment with multiple concurrent engineering initiatives.
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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Jyothi Shiva
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