CSV Specialist

Walker Cole International is supporting an exciting biotech in Europe, a specialist quality control provider to the cell & gene therapy and biologics sector, in the appointment of a Computerised Systems Validation (CSV) Specialist on a short-term basis.

This opportunity is to lead and develop compliant validation strategies for computerised systems supporting QC and data management activities within a GxP-regulated environment.

The role will focus on server and backup system validation, lifecycle documentation, and ensuring data integrity, security, and regulatory compliance as this company looks to continue to scale its quality infrastructure.

Key responsibilities:

• Define and implement a CSV strategy aligned with EU Annex 11, 21 CFR Part 11, and GAMP 5.
• Author, review, and maintain validation lifecycle documentation including Validation Master Plans, URS/FRS, Risk Assessments, IQ/OQ protocols, Traceability Matrices, and Validation Reports.
• Lead validation activities for servers, backup systems, and QC data management platforms.
• Establish and document robust backup, recovery, and business continuity procedures for critical systems.
• Collaborate cross-functionally with IT, QA, and QC to ensure systems are secure, compliant, and inspection-ready.
• Provide SME support during audits and regulatory inspections.
• Support the transition from paper-based to computerised systems while maintaining compliance throughout.

Required experience and skills:

• Demonstrated experience delivering CSV activities within GxP-regulated environments (pharma, biotech, ATMP, or similar).
• Strong working knowledge of Annex 11, 21 CFR Part 11, and GAMP 5.
• Hands-on experience validating servers, backup solutions, and data management systems.
• Proven ability to author and execute validation documentation across the full system lifecycle.
• Understanding of IT infrastructure supporting QC operations (servers, networks, backup and recovery systems).
• Strong documentation, stakeholder engagement, and risk assessment capabilities.
• Must be an EU citizen.

Working pattern:
Fully remote

Employment type:
Contract

Location:
Europe 

Keywords:
CSV Specialist | Computerised Systems Validation | Annex 11 | 21 CFR Part 11 | GAMP 5 | Data Integrity | Server Validation | Backup Systems | QC Systems | Cell & Gene Therapy | Biologics | GxP | Remote

ID: 91980