GMP Validation Specialist

GMP Validation Specialist

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This range is provided by The Pirbright Institute. Your actual pay will be based on your skills and experience – talk with your recruiter to learn more.

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Hours
: 37 hours

Employment Type
:
Fixed Term/Full Time

Contract Length
:
Fixed-term contract until September 2027

Closing Date
: 22 January 2026

The Pirbright Institute

The Pirbright Institute delivers world-leading research to understand, predict, detect and respond to viral disease outbreaks. We study viruses of livestock that are endemic and exotic to the UK, including zoonotic viruses, by using the most advanced tools and technologies to understand host-pathogen interactions in animals and arthropod vectors. Our major strength in understanding the immune systems of livestock provides a platform to control current diseases and respond to emerging threats.

This important research would not be possible without the proportionate use of animals, which are integral to the development of new disease control measures such as vaccines and diagnostics. We have an establishment-wide commitment to the 3

Rs (replacement, reduction and refinement), high standards of animal welfare, a culture of care and openness.

Our Institute is made up of a dynamic and vibrant community of staff covering a diverse set of chosen fields, backgrounds and experience. We all play a crucial role in furthering the Institute’s aspirations, advancing the frontiers of science and knowledge through our excellent scientific research, knowledge sharing and contribution; with a real focus in improving the world in which we live.

Our outlook is always balanced by our strong sense of purpose, values and behaviours and an unwavering commitment to a ‘one Institute’ approach.

The GMP Validation Specialist will sit within the CVIM QA function, working closely with the CVIM Process Team to ensure the compliant status of the facility, equipment, utilities, and scientific process systems.

Reporting to the Head of Quality & Organisation, the postholder will have day-to-day responsibility for effectively leading, coordinating, executing, and maintaining validation and qualification activities across the CVIM GMP Facility.

This role requires a technically capable, self-driven individual who can work both autonomously and collaboratively. The post provides an opportunity to drive improvements, contribute to validation strategy design, and actively support the institute’s ambition to maintain a strong and proactive Quality Culture.

• Lead on the development, implementation, and ongoing maintenance of the CVIM Validation Strategy, ensuring alignment with regulatory expectations and industry best practice.
• Conduct risk assessments to inform validation approaches and lifecycle activities.
• Own the Validation Master Plan, ensuring its compliance to GMP regulations.
• Proactively lead on the improvement of validation processes.

• Lead on qualification and validation activities across the facility, including:
• Design Qualification (DQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Ensure documentation generated during validation lifecycle is complete, traceable, and compliant.
• Identify training requirements associated with equipment, process, or system validation activities.

• Draft and update Standard Operating Procedures (SOPs), validation protocols, and reports.
• Translate regulatory requirements into practical and clear procedures.
• Lead change control assessments for equipment, systems, and processes.
• Coordinate process validation activities in collaboration with the CVIM Process Team.

• Act as a key point of contact for external suppliers, contractors, and service engineers during validation and qualification work.
• Support internal and external audits and regulatory inspections through preparation of documentation and evidence.
• Manage the…