CSV Engineer

About the role

The CSV Engineer will support a biopharmaceutical manufacturing site in West Dublin, delivering computer system validation (CSV) activities across technical projects. The role ensures compliance with cGMP, data integrity and regulatory requirements while providing independent quality oversight for GxP systems.

Key responsibilities

• Act as the CSV Subject Matter Expert for MES, DCS, automated equipment and related infrastructure.
• Prepare, review and approve validation lifecycle documents such as plans, user requirements, risk assessments, protocols and reports.
• Develop and execute risk‑based CSV strategies for new and existing systems.
• Support project teams to align validation activities with timelines and regulatory guidelines (cGMP, GAMP 5, Annex 11, 21 CFR Part 11).
• Review equipment specifications, design and qualification documentation.
• Generate, manage and resolve validation deviations and documentation issues.
• Participate in investigations, data‑integrity assessments and periodic system reviews.
• Assist with regulatory inspections, internal audits and SOP maintenance.

Required profile

• Degree in Engineering, Life Sciences, Computer Science or related discipline (preferred).
• 5‑7 years of experience in Computer System Validation within a regulated biopharma or life‑sciences environment.
• Strong knowledge of cGMP, GAMP 5, Annex 11 and 21 CFR Part 11.
• Hands‑on experience validating GAMP Category 3‑5 systems.

Required skills

• Computer System Validation
• GAMP 5
• Annex 11
• 21 CFR Part 11
• MES
• DCS
• Automated equipment validation
• Risk assessment and data integrity

What we offer

• Opportunity to work in a cutting‑edge biopharmaceutical manufacturing environment.
• Collaboration with multidisciplinary engineering, quality and operations teams.
• Professional development in regulatory compliance and validation engineering.