Computer Systems Validation Engineer

Compliance Group Inc; Liverpool; On-site; GBP 55,000 - 75,000; Full time

Job summary

Compliance Group Inc. is seeking an experienced CSV Engineer in Liverpool, onsite, to support a large-scale GxP validation and remediation project. You will manage multiple workstreams across computerized systems.

Key responsibilities include developing CSV plans, reviewing CSRA and PQE, and installing/qualifying audit trails, IP clocks, and Wonderware/user management for Pall water. Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity is required.

Qualifications

• Must have strong, hands-on CSV experience in pharma or life sciences.
• Solid knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, GxP, and Data Integrity.
• Experience with CSRA, audit trails, user access management, CSV documentation, IQ/OQ/PQ.
• Experience with HMI/SCADA, manufacturing/lab systems, and server/infrastructure qualification.

Responsibilities

• Develop CSV Plans aligned with QMS and perform procedure gap assessments.
• Review CSRA and PQE files per GAMP 5 guidance.
• 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 Pall water system.
• Support and validate Octoplant server activities.
• Install and validate GxP Manager.
• Review and standardize HMI naming conventions for traceability.
• Prepare and execute risk assessments, IQ/OQ/PQ protocols, tests, deviations and validation reports.
• Collaborate with Quality, Engineering, IT, Automation, Laboratory and site teams for data integrity.

Skills

CSV experience

GAMP 5 knowledge

21 CFR Part 11

EU Annex 11

Data Integrity

HMI/SCADA

server/infrastructure qualification

Onsite availability

IQ/OQ/PQ documentation

Audit trails

Tools

Wonderware

Octoplant

GxP Manager

Job description

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.