Commissioning Lead - Biologics - UK in Newcastle Upon Tyne

Job description

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.

Extra information

Status

Open

Education Level

Secondary School

Location

Newcastle Upon Tyne

Type of Contract

Part-time jobs

Published at

19-06-2025

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English