CSV Subject Matter Expert – 6-Month Contract

About the role

This 6‑month contract position supports a leading pharmaceutical manufacturing site in Galway, focusing on Computer System Validation (CSV) within a GxP environment. The specialist will own validation activities, ensure compliance, and provide guidance to cross‑functional teams.

Key responsibilities

• Prepare, execute, review, and report GxP computerized system validation deliverables.
• Maintain the validated state of GxP computerized systems.
• Support CSV compliance across site systems and projects.
• Review protocols, create CSV documentation, QMS records, and technical reports.
• Manage change controls, deviations, investigations, CAPAs, and remediation activities.
• Conduct periodic reviews, ensure audit readiness, and update CSV procedures.
• Train and support cross‑functional teams on CSV‑related processes.

Required profile

• 4–6 years of experience in CSV, Computer Systems Validation, IT Quality, or a related GxP compliance role.
• Strong knowledge of regulatory expectations for GxP computerized systems.
• Excellent documentation skills for protocols, reports, risk assessments, and QMS records.
• Ability to work autonomously and drive CSV compliance across stakeholders.

Required skills

• Computer Systems Validation (CSV)
• GxP regulatory knowledge
• Risk assessment
• Protocol development
• Technical report writing
• QMS documentation