Commissioning Lead

We are looking for a team member on a consultancy/freelance basis for 2 years:

Ready to apply Before you do, make sure to read all the details pertaining to this job in the description below.

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 control
• Comfortable with ambiguity during a scale-up phase where not everything is defined in advance
• Genuinely motivated by the mission: enabling the supply of life-saving radiopharmaceuticals at scale