Reporting directly to the Engineering Capital Lead and acting 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 GxP-relevant IT/OT systems to ensure delivery in compliance with cGMP, 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 (GxP, 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 SM
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 (GxP, 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 GxP 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 GxP 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 GxP 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
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