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.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy