CSV Engineer

Our client, in the pharmaceutical sector, is seeking to hire a CSV Specialist to join their team. This position reports directly to the Engineering Capital Lead and, as CSV Specialist/Engineer, will act as the site Computer System Validation (CSV) Subject Matter Expert for the duration of the major Capital Project.

Provide CSV leadership and oversight to ensure all GxP‑relevant IT/OT systems within the capital project are delivered in compliance with cGMP, site procedures and applicable corporate standards.

Support internal and external cross‑functional teams (Engineering, Automation, IT/OT, Quality, Operations, vendors/contractors) to ensure timely and compliant execution of commissioning, qualification and validation activities.

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• Support preparation, review, and approval of Site Validation Master Plans (VMPs) and supporting plans/strategies for Facilities, Equipment, Utilities, Laboratory Methods, Process, and Computerised Systems.
  
• Define and maintain site CSV frameworks including CSV Plan, templates, SOP/work instruction inputs, and project validation deliverable’s structure.
  

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• Provide CSV leadership / support to project teams to ensure commissioning, qualification, and validation activities for IT/OT infrastructure and manufacturing control systems are executed compliantly.
  
• Ensure validation readiness for project milestones (FAT/SAT, IQ/OQ/PQ, go‑live, handover to operations).
  

Own / author / review / approve (as applicable) CSV documents, including:

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• User Requirements (URS), Functional/Design Specs (FS/DS) where applicable
  
• Configuration / Build documentation and design reviews
  
• Risk assessments (system impact, GxP criticality, data integrity, cybersecurity impact where required)
  
• Test strategies and protocols (FAT/SAT leveraging, IQ/OQ/PQ, regression testing, periodic review)
  
• Validation / qualification reports, release memos, and handover packages
  
• SOP / WI impacts, training requirements, and operational readiness evidence
  
• Master recipe / recipe management controls and change documentation (where relevant to the platform)
  

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• Deviations / defects are logged, triaged, investigated, and resolved with appropriate CAPA where required
  
• Retesting and impact assessments are performed and documented
  

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• ALCOA+ principles embedded in procedures and test evidence expectations
  
• Data flow mapping, critical data identification, audit trail review expectations, retention / archiving, backup/restore verification
  

Ensure robust change control for validated systems including:

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• Impact assessments (GxP, data integrity, security, business continuity)
  
• Validation strategy for changes (re‑test scope, regression, requalification)
  
• Version/configuration control and release management evidence
  
• Support / lead periodic reviews, validation maintenance plans, and system lifecycle documentation updates
  

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• B.Eng or equivalent experience in life science or engineering; knowledge in validation and quality compliance (cGMP / ICH / FDA / USP / EU policies/guidelines).
  
• In depth knowledge of FDA 21CFR pt11 and ANNEX 11 regulatory requirements.
  
• Experience in ISA95 and ISA88 standards from a Qualification perspective.
  
• At least 4 years Validation experience in Computer System Validation and Engineering / Commissioning experience.
  
• Validation experience with DCS / SCADA control systems and associated equipment, support equipment, utility systems, computerized systems/automation, periodic reviews, cleaning and process validation.
  
• Validation Experience in IT/OT and Shopfloor integrated control system qualification and data integrity processes.
  
• Demonstrated experience delivering Computer System Validation (CSV) activities for GxP computerized systems across the full lifecycle. xcfaprz
  
• Strong capability to work to standard work with high attention to detail; self‑directed, organized, and able to take initiative with minimal supervision.