Lab System Validation Analyst - Dunboyne (Ireland)
Posted Today by Xpertise
Negotiable
Outside
Hybrid
Dunboyne, Ireland, UK
Summary: The Lab Systems Validation Analyst role involves supporting validation activities for laboratory systems within a regulated GxP environment. The position requires leading computer system validation activities and ensuring compliance with relevant regulatory standards. The contract is initially set until June 2026, with a strong likelihood of extension. The role is based in Dunboyne, County Meath, Ireland, and offers a hybrid working arrangement.
Key Responsibilities:
- Lead computer system validation (CSV) activities for laboratory systems and instruments
- Produce and review validation documentation including URS, validation plans, IQ, OQ, PQ and reports
- Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity standards
- Support risk assessments, system changes and new system implementations
- Work closely with QA, IT and laboratory teams to maintain validated systems
Key Skills:
- 3+ years experience in computer system validation within a GxP laboratory environment
- Experience working with lab systems such as LIMS, ELN or CDS platforms
- Strong knowledge of regulatory standards including GAMP 5 and 21 CFR Part 11
- Experience producing validation documentation and executing test protocols
Salary (Rate): £450 daily
City: Dunboyne
Country: Ireland
Working Arrangements: hybrid
IR35 Status: outside IR35
Seniority Level: Mid-Level
Industry: Other
Lab Systems Validation Analyst
Location: Dunboyne, County Meath, Ireland (hybrid)
Contract: €520 per day
Start: ASAP
Duration: Initial contract until June 2026 with strong likelihood of extension
A global life sciences organisation is seeking an experienced Lab Systems Validation Analyst to support validation activities across laboratory systems within a regulated GxP environment.
Responsibilities:
Lead computer system validation (CSV) activities for laboratory systems and instruments
Produce and review validation documentation including URS, validation plans, IQ, OQ, PQ and reports
Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity standards
Support risk assessments, system changes and new system implementations
Work closely with QA, IT and laboratory teams to maintain validated systems
Experience Required:
3+ years experience in computer system validation within a GxP laboratory environment
Experience working with lab systems such as LIMS, ELN or CDS platforms
Strong knowledge of regulatory standards including GAMP 5 and 21 CFR Part 11
Experience producing validation documentation and executing test protocols
This is a contract opportunity to join a high profile programme supporting laboratory systems in a regulated pharmaceutical environment.