CSV Validation Specialist
We are seeking an experienced Computer System Validation (CSV) Specialist to support the delivery of a major capital programme within a highly regulated manufacturing environment. This role provides CSV leadership and subject‑matter expertise across IT/OT, automation and manufacturing control systems, supporting projects from design through commissioning, validation and handover to operations.
You will work closely with Engineering, Automation, IT, Quality, Operations and external vendors to ensure all GxP‑relevant systems are delivered in full compliance with regulatory requirements, internal standards and industry best practice.
Key Responsibilities
- Act as the CSV subject‑matter expert for capital projects, ensuring compliant delivery of GxP‑relevant computerized systems
- Support development, review and execution of Validation Master Plans (VMPs) and project‑specific validation strategies
- Define and maintain CSV frameworks, plans, templates and lifecycle documentation aligned to risk‑based validation principles (e.g. V‑Model)
- Provide CSV leadership across IT/OT infrastructure, automation and manufacturing control systems (PLC/SCADA/DCS/PCS)
- Ensure validation readiness for project milestones including FAT, SAT, IQ/OQ/PQ, go‑live and operational handover
- Author, review and approve CSV documentation including URS, risk assessments, RTMs, test protocols, reports and release documentation
- Oversee validation testing execution, deviation management, impact assessments and CAPA closure
- Act as a CSV and Data Integrity SME, embedding ALCOA+ principles and supporting audit and inspection readiness
- Support change control, system lifecycle management and periodic reviews for validated systems
- Assess and manage vendors and outsourced service providers, including leveraging supplier documentation and testing
- Collaborate with IT/OT and cybersecurity teams to ensure infrastructure and security controls support GxP compliance
- Track and report validation KPIs, risks, milestones and project readiness
- Promote a strong quality culture, continuous improvement mindset and compliance‑first execution
About You
- Degree qualified (or equivalent experience) in engineering, life sciences or a related discipline
- Minimum 4+ years' experience in Computer System Validation within a regulated manufacturing environment
- Strong knowledge of cGMP, FDA 21 CFR Part 11, EU Annex 11 and data integrity requirements
- Experience validating IT/OT systems, automation platforms and manufacturing control systems
- Familiarity with ISA‑88 and ISA‑95 standards from a validation perspective
- Proven ability to author high‑quality validation documentation and manage complex validation programmes
- Confident communicator, able to influence cross‑functional stakeholders and escalate risks appropriately
- Highly organised, self‑directed and comfortable managing multiple priorities concurrently
- Continuous improvement mindset with a pragmatic, risk‑based approach
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