Posted 19 June, 2026
Sr. Computer System Validation (CSV) Engineer
Aligned Automation
Limerick, Limerick, Ireland
Full Time
Reference: 1365524878
Job Description
Senior Computer System Validation (CSV) Engineer
Location: Limerick, Ireland
Job Type: Full-TimeExperience: 10+ YearsEligibility: EU Nationals Preferred
Role Overview
We are seeking an experienced Senior CSV Lead to manage validation and compliance activities for GxP-regulated computerized systems within a pharmaceutical manufacturing environment. The role requires strong expertise in Computer System Validation (CSV), Software Validation, IQ/OQ/PQ execution, Data Integrity, and regulatory compliance.
The successful candidate will lead validation lifecycle activities for manufacturing, laboratory, automation, and enterprise systems while ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements.
Key Responsibilities
Required Qualifications
Preferred
Senior Computer System Validation (CSV) Engineer
Location: Limerick, Ireland
Job Type: Full-TimeExperience: 10+ YearsEligibility: EU Nationals Preferred
Role Overview
We are seeking an experienced Senior CSV Lead to manage validation and compliance activities for GxP-regulated computerized systems within a pharmaceutical manufacturing environment. The role requires strong expertise in Computer System Validation (CSV), Software Validation, IQ/OQ/PQ execution, Data Integrity, and regulatory compliance.
The successful candidate will lead validation lifecycle activities for manufacturing, laboratory, automation, and enterprise systems while ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements.
Key Responsibilities
- Lead end-to-end CSV lifecycleactivities for GxP systems.
- Develop and execute IQ/OQ/PQprotocols and validation documentation.
- Review and approve URS, RiskAssessments, Traceability Matrices, and Validation Summary Reports.
- Support validation of MES, LIMS,SCADA, ERP, laboratory, and manufacturing systems.
- Ensure compliance with GAMP 5, 21 CFRPart 11, EU Annex 11, and ALCOA+ principles.
- Manage change controls, deviations,CAPAs, and periodic reviews.
- Support audits and regulatoryinspections.
- Collaborate with QA, IT, Engineering,Manufacturing, and Automation teams.
- Mentor junior validation engineersand support site projects.
Required Qualifications
- Bachelor's degree in Engineering,Computer Science, Life Sciences, or related field.
- 10+ years of CSV experience inpharmaceutical or biotech manufacturing.
- Strong expertise in:
- Computer System Validation (CSV)
- Software Validation
- IQ/OQ/PQ
- Data Integrity
- GxP Compliance
- Hands-on experience with regulatedmanufacturing and laboratory systems.
- Strong knowledge of FDA 21 CFR Part11, EU Annex 11, and GAMP 5.
Preferred
- Experience with MES, SCADA, LIMS,SAP, DeltaV, or similar GxP platforms.
- Exposure to cloud/SaaS validation andautomation systems.
- ISPE, ASQ, PMP, or CSV-relatedcertifications preferred.
