Automation & Computer System Validation (CSV) Engineer Lead

I'm urgently seeking an experienced Automation Engineer with strong CSV capabilities to join a major capital project team in the biotech/pharmaceutical sector. This is a hands-on leadership position guiding both the automation architecture and CSV qualification of GxP Computerised Systems for a significant greenfield/brownfield manufacturing facility.

You will lead the overall automation and 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 automation system design, configuration, and CSV validation methodology across the program
• Develop, configure, and commission DCS/PLC automation systems (Rockwell PlantPAx 5.0 essential) with full GxP compliance
• Manage and mentor the automation/CSV team, ensuring deliverables meet project schedules
• Author automation design specifications, code, and configuration alongside key CSV documentation: Validation Plans, URS, Risk Assessments, protocols, and summary reports
• Develop and execute Change Controls and quality records for system updates
• Establish GxP 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 automation integration and qualification requirements are met
• Attend Factory Acceptance Tests (FAT) in Ireland or abroad as required
• Represent Automation/CSV at monthly stakeholder reporting meetings

Requirements

• Degree in relevant engineering discipline or 10+ years' experience in biotech/pharma automation and CSV
• Proven leadership experience managing automation and/or CSV teams and workloads
• Hands-on expertise with DCS/PLC systems (Rockwell PlantPAx 5.0 essential) — configuration, programming, and commissioning
• Significant project lifecycle experience in GxP automation system implementation with integrated risk-based CSV validation
• Strong knowledge of BMS (IQ Vision), HVAC, WFI (Veolia), Autoclaves (Fedagari), and Optima filling lines — including automation interfaces and control strategies
• 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 the 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 Corey@ApexGlobalResources.com or call me, Corey Buckley, Recruitment Consultant – Head of Life Sciences – US/Europe, at +353 (87) 283 9994. Please feel free to visit my LinkedIn profile to see my references/recommendations.