Commissioning Lead

Planet Pharma; Mol; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Planet Pharma seeks an experienced Commissioning Lead to drive end‑to‑end commissioning for a highly regulated pharmaceutical facility on a 2‑3 year consultancy assignment in Belgium.

You will coordinate planning, testing, and handover to operations, ensuring GMP compliance and managing cross‑functional teams across facilities, utilities, and control systems. Fluency in English is required and prior pharma/regulatory experience is preferred.

Qualifications

• 10-15 years of experience delivering commissioning activities in complex industrial or regulated environments.
• Strong knowledge of commissioning methodologies including IQ/OQ/PQ, FAT/SAT, testing protocols and commissioning documentation.
• Experience in GMP-regulated industries is essential.

Responsabilités

• Develop, own, and maintain the master commissioning strategy and sequence across all systems and workstreams.
• Define commissioning milestones, integrated testing activities, and handover gates.
• Collaborate with project planning teams to ensure commissioning is integrated into the overall project schedule.
• Identify and manage dependencies between facility infrastructure, utilities, process equipment, and control systems.
• Lead integrated commissioning and cross-functional testing activities and ensure readiness before handover.
• Coordinate with equipment suppliers, third parties, and regulatory stakeholders as required.
• Maintain the commissioning register and track readiness, acceptance status, and progress.
• Support the transfer of commissioning data into maintenance and asset management systems.

Connaissances

Commissioning leadership

IQ/OQ/PQ knowledge

Regulatory compliance

Description du poste

Commissioning Lead (Contract/Freelance) | 2-3 Year Assignment

We are seeking an experienced Commissioning Lead to support the delivery of a highly regulated industrial facility. This is a long-term consultancy/freelance opportunity (2-3 years) for a professional with a strong background in commissioning complex engineering projects within pharmaceutical, nuclear, biotech, or similarly regulated environments.

The Opportunity

As the Commissioning Lead, you will be responsible for the end-to-end coordination and execution of the commissioning phase across building, process, and utility systems. You will ensure the safe, compliant, and efficient integration and handover of systems to operations, while maintaining alignment with GMP and applicable regulatory requirements.

Key Responsibilities

Commissioning Planning & Sequencing

• Develop, own, and maintain the master commissioning strategy and sequence across all systems and workstreams.
• Define commissioning milestones, integrated testing activities, and handover gates.
• Collaborate closely with project planning teams to ensure commissioning activities are fully integrated into the overall project schedule.
• Identify and manage dependencies between facility infrastructure, utilities, process equipment, and control systems.

System Integration & Testing

• Lead the planning and execution of integrated commissioning and cross-functional testing activities.
• Ensure systems are tested and verified under representative operating conditions prior to handover.
• Coordinate activities involving equipment suppliers, qualified third parties, and regulatory stakeholders where required.
• Manage change control processes throughout the commissioning lifecycle, ensuring all changes are appropriately documented and implemented.

Commissioning Governance

• Maintain the commissioning register and track system readiness, acceptance status, and progress.
• Ensure readiness criteria and stage-gate requirements are met before systems advance to integrated testing.
• Identify, elevate, and help resolve project risks and commissioning blockers.
• Support the development and review of FAT and SAT protocols as required.

Operational Handover

• Serve as the primary interface between project and operations teams during commissioning and startup activities.
• Ensure all commissioning records and documentation are complete, traceable, and inspection-ready.
• Support the transfer of commissioning data into maintenance and asset management systems.
• Facilitate a structured and documented handover of systems to operations teams.
• Promote early operational involvement to ensure a seamless transition to routine operation.

Safety Leadership

• Provide daily oversight of commissioning activities involving live systems.
• Review and challenge method statements and work permits associated with commissioning and construction activities.
• Manage lockout/tagout (LOTO) processes where applicable to ensure the safe isolation and protection of systems.

About You

• 10-15 years of experience delivering commissioning activities within complex industrial or regulated project environments.
• Proven experience leading or playing a senior role within commissioning teams on major facility, infrastructure, or process projects.
• Strong knowledge of commissioning methodologies, including IQ/OQ/PQ, FAT/SAT, testing protocols, and commissioning documentation.
• Broad technical understanding across facilities, utilities, HVAC, electrical, automation, process, and control systems.
• Experienced in managing cross-functional stakeholders and multi-contractor environments.
• Comfortable making critical decisions, enforcing readiness criteria, and escalating issues when necessary.
• Experience within GMP-regulated industries is essential.
• Experience in nuclear, radiopharmaceutical, or highly regulated environments would be advantageous.
• Fluent English communication skills; additional European languages are considered beneficial.

Personal Attributes

• Highly organised, structured, and detail-oriented.
• Pragmatic and solutions-focused with the ability to maintain project momentum.
• Strong collaborator who excels at bringing teams together around common objectives.
• Comfortable working within evolving project environments where priorities may shift.
• Motivated by delivering technically complex projects that contribute to improving patient outcomes and advancing healthcare innovation.

Contract Type: Consultancy/Freelance
Duration: 2-3 years
Location: Belgium (site-based)
Industry: Advanced Pharmaceutical / Life Sciences Manufacturing Facility