CSV Engineer

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:

• BEng 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.

Please note, we do not require agency assistance with this role.