Computer Systems Validation Engineer

Location: Liverpool, UK – Onsite

Duration: ~12 Months

Industry: Pharmaceutical / Life Sciences

Role Overview

Seeking an experienced CSV Engineer to support a large-scale GxP validation, remediation, qualification, and systems improvement project. The role involves managing multiple workstreams across computerized systems.

Key Responsibilities

• Develop CSV Plans aligned with QMS and perform procedure gap assessments.
• Review Computerized System Risk Assessments (CSRA) and PQE files in line with GAMP 5 .
• Install and qualify audit trails for 506/507 systems.
• Qualify Dryers 506/507 with server-time synchronization.
• Install and qualify IP clocks across the site.
• Implement and validate Wonderware/user management for the Pall water system.
• Support and validate Octoplant server activities.
• Install and validate GxP Manager .
• Review and standardize HMI naming conventions for improved traceability.
• Prepare and execute risk assessments, IQ/OQ/PQ protocols, test scripts, deviations, and validation reports .
• Collaborate with Quality, Engineering, IT, Automation, Laboratory, and site teams to ensure GxP and data-integrity compliance.

Must-Have Skills

• Strong hands-on CSV experience in Pharmaceutical, Biotechnology, Medical Device, or Life Sciences.
• Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, GxP, and Data Integrity .
• Experience with Computerized System Risk Assessments, audit trails, user access management, CSV documentation, IQ/OQ/PQ .
• Experience with HMI/SCADA, manufacturing/laboratory systems, and server/infrastructure qualification .
• Onsite availability in Liverpool, UK and ASAP start .

Nice to Have

Wonderware, Octoplant, GxP Manager, Pall water systems, audit-trail implementation, and industrial automation experience.