CSV Engineer - GMP Validation & Compliance Specialist

CareerWise Recruitment; Munster; On-site; EUR 60,000 - 80,000; Full time

Job summary

CareerWise Recruitment is seeking a CSV Engineer for our Waterford based client. The contract is 12 months.

The role covers execution and support of the CSV lifecycle across manufacturing, laboratory, and utility systems, with responsibility for validation documentation and ensuring GxP compliance (Annex 11, 21 CFR Part 11).

The ideal candidate will have 2–3 years in CSV/automation within GMP environments, strong GAMP 5 knowledge, and collaboration with QA, IT, Eng and Ops.

Qualifications

• Experience with CSV for manufacturing, laboratory, utility, or quality systems.
• Validation of PLC, SCADA, HMI, and automated control systems.
• Data integrity assessments and Annex 11 / 21 CFR Part 11 compliance.

Responsibilities

• Execute and support the full CSV lifecycle, including planning, testing, implementation, and periodic reviews.
• Develop, review, and maintain validation documentation (IQ/OQ/PQ, DQ, Validation Plans, Traceability Matrix).
• Collaborate with QA, IT, Engineering, and Operations to ensure GxP compliance and regulatory readiness.
• Lead validation activities for new system implementations, upgrades, and infrastructure changes.
• Investigate deviations, incidents and change controls to assess validation impact and ensure continued compliance.
• Support internal audits and regulatory inspections with validation documentation and SME input.

Skills

GAMP 5

CSV lifecycle

cGMP compliance

Data integrity

Education

Engineering/CS/Life Sciences degree

Tools

GxP tools

Job description

CareerWise Recruitment is seeking a CSV Engineer for our Waterford based client. The contract is 12 months.

The role covers execution and support of the CSV lifecycle across manufacturing, laboratory, and utility systems, with responsibility for validation documentation and ensuring GxP compliance (Annex 11, 21 CFR Part 11).

The ideal candidate will have 2–3 years in CSV/automation within GMP environments, strong GAMP 5 knowledge, and collaboration with QA, IT, Eng and Ops.