Computer System Validation Specialist; CSV

Position Summary

The Computer System Validation (CSV) Specialist is responsible for the governance, validation, and lifecycle management of all GxP-relevant computerised systems at site.

This role ensures ongoing compliance with EU GMP Annex 11, MHRA Data Integrity Guidance, GAMP5 principles, and applicable global regulatory requirements. The position provides technical oversight of electronic systems, manages validation activities, assesses system updates and changes, and closes existing CSV compliance gaps to maintain inspection readiness and data integrity.

• Own and maintain the site Computerised Systems Validation (CSV) Master Plan.
• Manage the full validation lifecycle of GxP systems (URS, risk assessment, IQ/OQ/PQ, validation reports).
• Assess and approve system updates, configuration changes, and upgrades in line with change control procedures.
• Conduct risk-based impact assessments for system changes and new implementations.
• Perform and document periodic system reviews to ensure ongoing validated state.
• Identify and close existing CSV gaps to ensure compliance with Annex 11 and data integrity requirements.
• Eudra Lex Volume 4 Good Manufacturing Practice (GMP) guidelines, laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively
• UK Good Laboratory Practice Regulations 1999, Statutory Instrument No. 3106 as amended by Statutory Instrument 2004/994
• OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring No1
• OECD Principles of Good Laboratory Practice ENV/MC/CHEM(98)17
• OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Nos. 2-25
• MHRA ‘GxP’ Data Integrity Guidance and Definitions March 2018
• US 21 CFR Part 11
• US 21 CFR Part 210 & 211 (US GMPs)
• Ensure appropriate audit trail review processes are defined and implemented.
• Support supplier qualification and oversight of SaaS/cloud-based system providers.
• Provide inspection support for MHRA and other regulatory authorities.
• Collaborate with QA, IT, Operations, and external vendors to ensure compliant system management.
• Develop and maintain CSV templates, procedures, and best practices aligned with GAMP5 principles.
• Standard bullet list item for all people manager positions:

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Computer Science, or a related scientific discipline (or equivalent relevant experience).
• Minimum 3–5 years’ experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical, biotechnology, or clinical research environment.
• Demonstrated hands‑on experience with Master Control (or equivalent eQMS), including configuration assessment, validation, and lifecycle management.
• Practical experience validating GxP computerised systems in accordance with EU GMP Annex 11 and GAMP
  5.
• Experience conducting system risk assessments, change impact assessments, and periodic reviews.
• Experience supporting regulatory inspections (e.g., MHRA, FDA) relating to computerised systems and data integrity.

• Strong knowledge of EU GMP Annex 11 requirements.
• Good understanding of MHRA Data Integrity Guidance and ALCOA+ principles.
• Knowledge of GAMP5 risk‑based validation methodology.
• Understanding of 21 CFR Part 11 (where applicable).
• Knowledge of computerised system lifecycle management in a regulated environment.
• Ability to prepare and review validation documentation (URS, IQ/OQ/PQ, validation reports).
• Strong analytical and risk assessment skills.
• Ability to assess system changes and determine validation impact.
• Strong written and verbal communication skills.
• Ability to manage multiple validation projects and priorities simultaneously.
• Effective cross‑functional collaboration skills (QA, IT, Operations, external vendors).
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.

• None

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable…