Computer Systems Validation Project Manager

at  NHS Professionals

Job Introduction
The United Kingdom Health Security Agency (UKHSA) protects the nation from infectious diseases and external hazards, offering trusted advice to the government and public on outbreak management. The Vaccine Development and Evaluation Centre at UKHSA Porton is a cutting-edge research facility focused on developing and testing vaccines and therapeutics for COVID-19 and other health threats.
The Validation Project Manager will oversee computer systems validation project delivery for GxP regulated operations within the Centre. Responsibilities include coordinating vendor teams, 3rd party validation partners, and UKHSA staff to ensure successful project delivery. The role also involves developing and reviewing validation control documentation (e.g., VMP, VSR) and guiding end users in executing test protocols (IQ/OQ/PQ). When third-party partners are involved, the Project Manager will oversee their work, conduct gap analyses, and ensure all documentation is properly integrated into the project validation document set.

Main Responsibilities

• Provide computer system validation leadership and support for the delivery of GxP compliant computer system implementation projects.
• Report on validation project progress and issues to facility management.
• Develop validation plans for computer system implementation projects.
• Conduct gap analyses of supporting validation documentation and identify additional testing requirements.
• Conduct reviews of vendor documentation and completed validation test documentation.
• Liaise with internal and external implementation resources to deliver compliant computer system solutions.
• To maintain health and safety competence to the national occupational standard ‘Make sure your actions reduce risks to health and safety’ (NOS HSS1).
• To achieve and maintain own and team’s health and safety competence set out in national occupational standard ‘Identify, assess and control health and safety risks’ (NOS HSP6).
• To comply with all UKHSA policies and procedures.

The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by your line manager.

The Ideal Candidate

• Degree/Postgraduate degree in a relevant discipline and considerable experience in the specialised area (3+ years required).
• Specialist training/experience in specific methods, including equipment and computer systems validation.
• Extensive practical experience in the pharmaceutical industry, focusing on facilities, equipment, GxP Critical Utilities, and current validation technologies.
• Specialist experience in applying computer systems validation for GxP projects.
• Experience in project management of validation project delivery in a GxP environment.
• Subject Matter Expert (SME) in FDA/MHRA Regulatory inspections.