Commissioning Lead - Biologics - UK

Tandem Project Management Ltd.; Newcastle upon Tyne; On-site; GBP 55,000 - 75,000; Full time

Job summary

A leading company in project management is seeking a Commissioning Manager to oversee the transition from equipment installation to operational readiness at a state-of-the-art biotechnology facility in North East England. This mid-senior level role requires deep expertise in pharmaceutical plant commissioning and excellent stakeholder management skills to ensure timely project delivery to the highest standards.

Qualifications

• 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.

Responsibilities

• Lead the transition of systems from installation through commissioning to operational readiness.
• Manage delivery, installation, and commissioning of multiple process equipment vendor packages.
• Develop and maintain detailed handover schedules and proactively resolve issues.

Skills

Stakeholder Management

Project Management

GMP Knowledge

Organizational Skills

Leadership

Education

Degree in Engineering, Project Management, or related discipline

Job description

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Associate Director, Talent Solutions at Tandem Project Management Ltd.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Engineering Services and Pharmaceutical Manufacturing

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