Commissioning Lead
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We are looking for a team member on a consultancy/freelance basis for 2-3 years:
A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible.
Responsibilities
You are responsible for the end-to-end coordination of the commissioning phase across all facility systems – building, process, and utilities – ensuring that integrated handover to operations is achieved safely, on schedule, and in full compliance with GMP and nuclear regulatory requirements (including a strict commissioning plan involving the nuclear regulator).
Commissioning sequencing & planning
- Own and maintain the master commissioning sequence, defining the order of system acceptance, integrated testing milestones, and handover gates across all workstreams
- Work in close alignment with the Planning Engineer to ensure commissioning activities are fully integrated into the overall project schedule
- Identify and manage interdependencies between building systems (HVAC, electrical, civil) and process systems (irradiation, downstream processing, dispensing), in close collaboration with the various Project Managers
Integration & cross-system coordination
- Lead the design and execution of integrated and cross-system testing that spans multiple project manager scopes
- Ensure that building and process systems are validated under representative operating conditions before operational handover
- Coordinate the involvement of equipment vendors, third-party qualified persons, and regulatory bodies (including FANC) during commissioning activities
- Integrate change management process, ensuring that changes are properly documented, reviewed, approved, and reflected throughout the commissioning activities.
Gate enforcement & commissioning register
- Maintain the commissioning register, tracking acceptance status across all systems and subsystems
- Enforce readiness gates: no system proceeds to integrated testing before individual acceptance by the responsible project manager is complete and documented
- Escalate unresolved blockers directly to project leadership
- Contribute to the preparation and/or review of FAT protocols as needed
Handover to operations
- Act as the primary interface between the project team and the operations team during the commissioning and handover phase
- Ensure commissioning documentation is complete, traceable, and fit for purpose as regulatory records supporting qualification and future submissions (DMF, IMPD)
- Ensure commissioning documentation and data are structured so they can be easily transferred into the CMMS.
- Support a clean, documented transfer of each system to the Operations Manager
- Anticipate involvement of Operations in the commissioning phase to facilitate transfer to operation phase
Safety
- Daily follow-up of on-site activities involving live systems, with close communication with the construction team.
- Critical review of method statements for work on live systems, or in areas close to live systems, in close coordination with the construction team and the contractor. xlxgzvr
- LOTO(TO) management to safeguard live systems between construction phases or during change management activities (when applicable).
Profile
- You have 10–15 years of experience in industrial project environments, with a significant portion dedicated to commissioning roles in regulated industries (pharmaceutical, nuclear, or equivalent)
- You have directly led or been a senior member of a commissioning team on at least one major facility or process line, with hands-on experience in IQ/OQ/PQ workflows, FAT/SAT sequences, and commissioning documentation
- You think in systems: you understand how HVAC, electrical, process, and control systems interact, and you instinctively look for integration risks across discipline boundaries
- You are technically credible across multiple engineering domains without needing to be the deepest expert in any single one
- You hold your ground under schedule pressure — you are capable of enforcing gates and escalating when necessary, with the personal authority to make it stick
- Experience in a GMP-regulated environment is required; familiarity with nuclear licensing and radiation protection constraints is a strong asset
- You are comfortable operating as a coordination hub in a multi-contractor, multi-stakeholder environment without formal authority over most of the people you work with
- You are fluent in Dutch and English; French is an asset
You are also
- Rigorous and structured, but pragmatic enough to keep things moving in a dynamic project environment
- A natural integrator - your instinct is to connect and align, not to own and