Job Overview
Our organization is seeking an experienced CSV Engineer to join our team at a client site in Carlow. The ideal candidate will bring strong GMP manufacturing experience within the life sciences sector and play a key role in supporting site-wide Computer Systems Validation (CSV) and IT compliance activities.
Key Responsibilities include ensuring global SDLC, CSV, and IT Security policies are adhered to through effective planning coordination execution of project operational deliverables support management compliance processes including Change control Periodic reviews System performance monitoring System access administration Disaster recovery activities Deviations incidents investigations CAPAs Audits inspection readiness Policy deployment Cyber security data integrity initiatives EHS training adherence Operate Quality Management System QMS Chapter 14 EU Annex 11 CFR Part 11 MHRA UK GMP Data Integrity Guidelines Sarbanes-Oxley SOX Requirements ";
Requirements:
* Degree qualification in Science Engineering or related technical discipline.
* 3–5 years' GxP experience in Computer Systems Validation life sciences pharmaceutical medical device industry.