Commissioning Lead

PANTERA; Mol; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

PANTERA in Belgium seeks an experienced commissioning coordinator on a 2-year consultancy basis. You will lead end-to-end coordination of commissioning across building, process and utilities, ensuring safe, on-time handover to operations under GMP and nuclear regulatory requirements.

Work includes defining testing milestones, managing interdependencies, coordinating vendors and regulators, and maintaining documentation to support qualification and future submissions.

Qualifications

• 10–15 years in industrial project environments, with significant commissioning experience in regulated industries.
• Led commissioning teams on major facilities, with IQ/OQ/PQ, FAT/SAT, and documentation.
• Fluent in Dutch and English; French is a plus.
• Experience in GMP-regulated environments; nuclear licensing familiarity is an asset.

Responsabilités

• Coordinate end-to-end commissioning across building, process and utilities and ensure safe handover to operations in compliance with GMP and nuclear requirements.
• Define master commissioning sequences, milestone testing, and handover gates across all workstreams.
• Manage interdependencies between building and process systems; coordinate with vendors and regulators.
• Maintain commissioning register, ensure readiness gates, and escalate blockers to project leadership.
• Support preparation/review of FAT/SAT protocols and ensure documentation is fit for regulatory submissions.

Connaissances

Leadership

Systems thinking

Coordination

Regulatory understanding

Dutch language

English language

Problem solving

Description du poste

We are looking for a team member on a consultancy/freelance basis for 2 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
• 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.
• 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