CSV Specialist

Walker Cole International is supporting a leading pharmaceutical organisation in the appointment of a Computerised Systems Validation (CSV) Specialist to deliver validation and data integrity activities within a GMP environment.

This position will centre on overseeing validation projects and conducting data integrity assessments across computerised systems within a GxP-regulated metabolism environment. The successful candidate will contribute to ensuring compliance, robust documentation practices, and alignment with regulatory standards.

Key responsibilities:

• Oversee CSV projects and conduct data integrity assessments for computerised systems and laboratory-based instruments.
• Prepare and execute end-to-end validation lifecycle documentation, including Risk Assessments, Validation Plans, URS, Vendor Assessments, Configuration Specifications, Test Scripts, Traceability Matrices, UAT, Validation Reports, and SOPs.
• Ensure systems remain compliant with GxP requirements and that documentation is complete, accurate, and audit-ready.
• Manage and support deviations, incidents, and change controls throughout validation activities.
• Work closely with IT and cross-functional teams to define user and system requirements and support project execution.
• Maintain alignment of validation activities and SOPs with current regulatory expectations and industry best practices.
• Provide SME input during internal, sponsor, and regulatory inspections.
• Assist with the administration, maintenance, and ongoing support of computerised systems.

Required experience and skills:

• Proven experience delivering full lifecycle CSV activities within GxP-regulated environments.
• Strong understanding of CSV methodologies and GAMP 5 guidelines.
• Solid knowledge of data integrity principles and compliance requirements.
• Experience with laboratory systems, instruments, and associated software (desirable).
• Understanding of regulatory frameworks, including MHRA expectations and quality systems.
• Strong written and verbal communication skills with the ability to engage stakeholders effectively.
• Excellent computer literacy, particularly within software-driven environments.

Working pattern:
Onsite (with potential flexibility)

Employment type:
Contract

Location:
United Kingdom

Keywords:
CSV Specialist | Computerised Systems Validation | GAMP 5 | Data Integrity | GxP | GMP | Validation | Pharma | Compliance | SOPs | UAT | Risk Assessment

ID: 104433