Commissioning Lead - Biologics - UK

We are seeking a highly experienced and driven Commissioning Manager to oversee the transition from equipment installation through commissioning and handover to operations at our client’s state-of-the-art biotechnology start-up facility in North East England. This role requires a strong background in pharmaceutical plant commissioning and start-up and a proven ability to manage multiple equipment vendors and internal stakeholders to deliver on time and to the highest standards. Responsibilities: • Lead the transition of systems from installation through commissioning to operational readiness, ensuring all handover milestones are completed to project and GMP standards. • Manage the delivery, installation, and commissioning of multiple process equipment vendor packages, coordinating closely with vendors and internal CQV teams. • Implement and enforce robust Site Handover Processes, ensuring clear ownership transition from construction to commissioning and ultimately to operations. • Organise and facilitate P&ID walkdowns and system handover meetings with internal stakeholders, end users, and project engineering teams. • Serve as a primary liaison between cross-functional teams, ensuring that engineering, automation, operations, and quality stakeholders' needs are met or exceeded. • Develop and maintain detailed handover schedules, track progress against critical path, and proactively resolve issues that may delay startup readiness. • Ensure safety, quality, and compliance are upheld throughout all phases of commissioning and start-up. • Apply prior experience as a Commissioning Manager to drive operational readiness and support a smooth transition to commercial manufacturing. Qualifications & Experience: • Degree in Engineering, Project Management, or related discipline. • Extensive experience in commissioning and start-up of pharmaceutical or biotech manufacturing facilities. • Proven experience managing multiple vendor packages, FAT/SAT coordination, and equipment turnover. • Strong working knowledge of GMP, CQV lifecycle, and site acceptance and handover processes. • Excellent stakeholder management skills with the ability to balance competing priorities and communicate effectively at all levels. • Strong organisational and leadership skills, capable of managing detailed schedules and high volumes of concurrent system transitions.

Location: Newcastle Upon Tyne, GB

Posted Date: 6/30/2025