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.
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