Commissioning Lead

PANTERA; Mol; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

PANTERA is seeking a consultancy specialist for a 2-3 year engagement to coordinate commissioning across building, process and utilities, ensuring a safe, compliant handover under GMP and nuclear regulations.

You will lead the master sequencing, align with the project schedule, and drive integrated testing across systems. The role requires experience in IQ/OQ/PQ, FAT/SAT, and strong cross‑functional coordination with vendors and regulators.

Qualifications

• 10–15 years in industrial projects with commissioning in regulated industries.
• Led commissioning teams on major facilities with IQ/OQ/PQ workflows and FAT/SAT.
• Fluent in Dutch and English; French is an asset.

Responsabilités

• Coordinate end-to-end commissioning across building, process, and utilities for safe, on-time handover.
• Maintain master commissioning sequence and gating across workstreams.
• Coordinate with Planning Engineer to integrate activities into the project schedule.
• Lead cross-system testing and validate operations before handover.
• Engage vendors, qualified persons, and regulators (FANC) during commissioning.
• Ensure documentation is traceable and ready for regulatory records (DMF, IMPD).

Connaissances

Commissioning coordination

Regulatory compliance

GMP experience

IQ/OQ/PQ workflows

FAT/SAT sequences

Cross-system integration

Vendor & regulator liaison

Dutch & English fluency

Description du poste

We are looking for a team member on a consultancy/freelance basis for 2-3 years:

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.
• 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