This role reports directly to the Engineering Capital Lead and acts as the Computer System Validation (CSV) Subject Matter Expert for a major capital investment programme within a regulated manufacturing environment. The role provides CSV leadership and governance across all Gx P-relevant IT/OT systems to ensure delivery in compliance with c GMP, site procedures, and applicable corporate quality standards. The successful candidate will support cross-functional teams including Engineering, Automation, IT/OT, Quality, Operations, and external vendors to ensure compliant execution of commissioning, qualification, and validation activities across the full project lifecycle. Key Areas of Responsibility Validation Governance & Master Planning Support preparation and maintenance of Validation Master Plans (VMPs) for facilities, utilities, equipment, labs, and computerised systems Develop and maintain CSV frameworks, procedures, templates, and lifecycle standards Ensure risk-based validation approach (e.g., V-model) aligned to system criticality and scope Project CSV Delivery (IT/OT & Automation) Provide CSV leadership for IT/OT infrastructure and manufacturing control systems (PLC/SCADA/DCS/PCS) Define governance structures (RACI, system ownership, validation boundaries) early in lifecycle Ensure readiness for FAT, SAT, IQ/OQ/PQ, system release, and handover to operations Validation Documentation Ownership Own/author/review/approve (as applicable): URS and functional/design specifications Risk assessments (Gx P, data integrity, cybersecurity) Traceability Matrices (RTM) Test strategies, protocols, and execution (FAT/SAT/IQ/OQ/PQ) Validation reports, release documentation, handover packs SOPs, training impacts, operational readiness documentation Recipe management and change controls Execution Oversight (Testing & Deviations) Oversee validation testing ensuring audit-ready, traceable evidence Manage deviations, defects, CAPAs, retesting, and impact assessments Ensure segregation of duties, access control, and compliant execution Data Integrity & Compliance SME Act as site SME for CSV and data integrity Ensure ALCOA+ compliance across systems and documentation Support audit trail reviews, data lifecycle controls, and electronic records compliance (21 CFR Part 11 / EU Annex 11) Support inspection readiness and audits Change Control & Lifecycle Management Manage validation impact assessments for system changes (Gx P, data integrity, security, continuity) Define revalidation and regression testing strategies Maintain lifecycle documentation, periodic reviews, and system configuration control Vendor & Supplier Management Support qualification of Gx P system/service suppliers Review and approve vendor validation deliverables Ensure contractual validation responsibilities are defined and met Cybersecurity & Infrastructure Interface Collaborate with IT/OT to ensure validated cybersecurity controls Validate system hardening, access control, backup/restore, and disaster recovery Ensure security controls do not impact Gx P functionality Reporting, KPIs & Governance Develop validation dashboards (progress, risks, deviations, milestones) Provide regular reporting to governance forums Escalate risks and blockers with mitigation plans Stakeholder Engagement Participate in project governance and site tier meetings Work with Engineering, Automation, IT, Quality, Operations, and vendors Communicate validation status, risks, and decisions clearly Safety & Quality Ensure compliance with safety and regulatory requirements Promote strong quality and compliance culture Support continuous improvement initiatives Education & Experience Degree in Engineering, Life Sciences, or equivalent 4+ years CSV experience in regulated GMP environments Strong knowledge of GMP systems (21 CFR Part 11 / EU Annex 11) Experience with IT/OT and automation systems Experience in commissioning, qualification, validation lifecycle ISA-88 / ISA-95 knowledge advantageous Key Competencies Strong CSV lifecycle experience in Gx P environments Excellent documentation and technical writing skills Strong stakeholder management and cross-functional collaboration Strong planning, prioritisation, and multitasking ability High attention to detail and compliance mindset Ability to work independently and drive delivery Continuous improvement mindset with focus on efficiency and risk reduction Skills: Computer System Validation GMP CSV Validation Master Plans Distributed Control System Gx P FDA GMP Benefits: Hybrid Parking on site