Role Summary
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.
Core Duties and Responsibilities
Validation Governance & Master Planning
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.
Project CSV Delivery (IT/OT & Manufacturing Control Systems)
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).
Validation Documentation Ownership
Own / author / review / approve (as applicable) CSV documents, including:
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)
Execution Oversight: Testing, Deviations, and Defect Management
Deviations / defects are logged, triaged, investigated, and resolved with appropriate CAPA where required
Retesting and impact assessments are performed and documented
Data Integrity & Compliance SME
ALCOA+ principles embedded in procedures and test evidence expectations
Data flow mapping, critical data identification, audit trail review expectations, retention / archiving, backup/restore verification
Change Control & Lifecycle Maintenance
Ensure robust change control for validated systems including:
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
Minimum Qualifications and Experience
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.
Strong capability to work to standard work with high attention to detail; self‑directed, organized, and able to take initiative with minimal supervision.
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