I'm urgently seeking an experienced Computer System Validation (CSV) Engineer Lead to join a major capital project team in the biotech/pharmaceutical sector.
This is a hands-on leadership position guiding the CSV qualification of Gx P Computerised Systems for a significant greenfield/brownfield manufacturing facility.
You will lead the overall validation approach, ensuring compliance with site procedures and applicable regulations (FDA, EMA, ICH), while managing stakeholder relationships and delivering critical milestones on schedule.
Responsibilities Lead and guide the CSV validation methodology and program approach Manage and mentor the CSV team, ensuring deliverables meet project schedules Author and approve key documentation: Validation Plans, URS, Risk Assessments, protocols, and summary reports Develop and execute Change Controls and quality records for system updates Establish Gx P system specifications and SOPs aligned with industry standards Maintain Requirements Traceability Matrices and generate Data Lifecycle maps Collaborate with engineering disciplines and equipment vendors to ensure qualification requirements are met Attend Factory Acceptance Tests (FAT) in Ireland or abroad as required Represent CSV at monthly stakeholder reporting meetings Requirements Degree in relevant discipline or 10+ years' experience in biotech/pharma CSVProven leadership experience managing CSV teams and workloads Hands-on expertise with DCS systems (Rockwell Plant PAx 5.0 essential)Significant project lifecycle experience in Gx P system validation using risk-based approaches Strong knowledge of BMS (IQ Vision), HVAC, WFI (Veolia), Autoclaves (Fedagari), and Optima filling lines Deep understanding of regulatory requirements (GAMP 5, 21 CFR Part 11, Annex 11) and data integrity best practices Excellent documentation, communication, and problem-solving skills Full-time on-site availability required as project and automation testing progresses If you are looking for a new and refreshing role or have any questions about the position, then give me a call, drop me a message, or apply directly below and get ahead of the crowd I look forward to hearing from you.
For a confidential discussion about this role, or to apply, send your CV to or call me, Corey Buckley, Recruitment Consultant – Head of Life Sciences – US/Europe, at Please feel free to visit my Linked In profile to see my references/recommendations