Lead Commissioning Manager – GMP Radiopharma

Alsinova; Limburg; Sur place; EUR 100 000 - 160 000; Plein temps

Résumé du poste

Alsinova seeks an experienced Commissioning Lead to drive the commissioning and handover of a GMP and nuclear facility. You will manage strategy, sequencing, testing and gatekeeping across building, utilities, process and automation systems, coordinating vendors and regulatory stakeholders including FANC.

You will ensure documentation completeness, transfer to Operations/CMMS and safe execution of activities such as LOTO. Fluency in English is required, with French/Dutch a plus.

Qualifications

• 10+ years of experience in commissioning within pharmaceutical, nuclear or other highly regulated industries.
• Strong experience with FAT/SAT, IQ/OQ/PQ and GMP environments.
• Broad understanding of HVAC, utilities, process, electrical and control systems.
• Proven ability to coordinate multiple stakeholders and manage complex project interfaces.
• Fluent in English. French and/or Dutch is a plus.

Responsabilités

• Manage the overall commissioning strategy, sequencing, testing and handover plan.
• Coordinate integrated commissioning activities across building, utilities, process and automation systems.
• Lead cross-functional testing and ensure readiness for operational handover.
• Maintain the commissioning register and enforce acceptance and testing gates.
• Coordinate vendors, contractors, operations teams and regulatory stakeholders (including FANC).
• Ensure commissioning documentation is complete, compliant and transferable to Operations and CMMS.
• Drive safe execution of commissioning activities, including LOTO management.

Connaissances

Commissioning leadership

IQ/OQ/PQ validation

GMP environments

HVAC understanding

Stakeholder coordination

Regulatory liaison

English fluent

Description du poste

Alsinova seeks an experienced Commissioning Lead to drive the commissioning and handover of a GMP and nuclear facility. You will manage strategy, sequencing, testing and gatekeeping across building, utilities, process and automation systems, coordinating vendors and regulatory stakeholders including FANC.

You will ensure documentation completeness, transfer to Operations/CMMS and safe execution of activities such as LOTO. Fluency in English is required, with French/Dutch a plus.