GMP Validation Specialist

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 3Rs (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.

Organisation position and purpose

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.

Main duties and responsibility

Validation Strategy & Framework

• 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.

Validation & Qualification Lifecycle

• Lead on qualification and validation activities across the facility, including:
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • 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.

Procedures, Documentation & Change Control

• 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.

Audit & Inspection Support

• 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 resolution of CAPAs relating to validation or qualification activities.

Cross-Team Collaboration

• Promote effective collaboration between CVIM QA, CVIM Process Team, and wider Pirbright QA.
• Contribute to improvements that enhance productivity, compliance, and customer service.
• Maintain an inspection readiness, safe, and compliant working environment at all times.

 This job description is only an outline of the tasks, responsibilities and outcomes required of the role. The jobholder will carry out any other duties as may be reasonably required by his/her line manager. The job description and personal specification may be reviewed on an ongoing basis in accordance with the changing needs of The Pirbright Institute.

Specific requirements

 Essential:

• Degree (or equivalent) in a life sciences or related field.
• Strong proven technical understanding of GMP principles.
• Proven practical experience of validation and GxP qualification methodologies.
• Ability to interpret regulations and convert them into clear procedures and documentation.
• Strong organisational, time-management, and problem-solving skills.
• Excellent verbal and written communication, including the ability to explain technical concepts to non-technical audiences.
• Ability to train others (e.g., delivering presentations or procedural training).
• High attention to detail and ability to analyse work critically.

 Desirable:

• Experience working in a GMP QA.
• Experience acting as an internal auditor.
• Experience working in a Containment Level 2 (CL2) environment.
• Experience in a biomanufacturing, bioprocessing, or regulated laboratory environment.

Due to the nature of the work carried out by Pirbright, all successful applicants will be required to go through a comprehensive screening process including reference and qualification checks, financial and security clearances.

What we offer

• Generous Group Personal Pension Scheme and life cover (subject to age and earnings)
• 25 days annual leave per annum, pro rata, plus 10.5 public and privilege days
• Buy and sell annual leave
• Option to carry over up to two weeks annual leave
• Pirbright gym with subsidised membership
• Pirbright social club
• Pirbright Lifestyle Hub (employee discount site)
• Cycle to work
• Subsidised staff restaurant
• Childcare allowance
• Free onsite parking
• Electric Car charging facilities