Job title: CSV Engineer

Job type: Perm

Location: Wilmslow, Cheshire

The CSV is responsible for the implementation, validation and maintenance of GxP‑regulated electronic systems within a GMP environment. The role provides expert oversight of computerised systems validation (CSV) to ensure system compliance, data integrity and alignment with regulatory expectations.

Key Responsibilities

CSV & Regulatory Compliance

• Lead CSV activities across all GxP systems, ensuring compliance with cGMP and relevant regulatory guidelines.
• Maintain system validation in line with internal validation strategies and procedures.
• Support audits by preparing documentation and responding to regulatory queries.
• Conduct and document periodic reviews of validated systems.

Validation Delivery

• Create, execute and review validation plans, test scripts and reports.
• Ensure validation evidence is complete, accurate and compliant.
• Manage validation deviations and ensure timely investigation and closure.

Documentation & Lifecycle Management

• Write and review system specifications, technical documents, SOPs and work instructions.
• Support updates to procedures to maintain regulatory alignment.
• Provide lifecycle oversight from system selection through to ongoing maintenance.

Risk & Issue Management

• Lead risk assessments (e.g., FMEA) and root‑cause investigations.
• Define and verify mitigation actions and CAPA activities.

Subject Matter Expertise

• Act as CSV SME, advising teams and supporting system implementation projects.
• Participate in vendor assessments and system qualification activities.
• Recommend improvements to validation processes and system efficiency.

Skills & Experience

• Strong understanding of cGMP, GxP expectations and CSV principles.
• Proven experience producing and reviewing CSV documentation.
• Skilled in risk management, CAPA and validation project execution.
• Excellent technical writing and communication abilities.
• Ability to work in a fast‑paced, regulated environment and collaborate cross‑functionally.