Impact Engineering is currently recruiting an experienced CSV Engineer (3–5 years' experience preferred) to join the CSV team at a client site in Carlow.
The successful candidate will bring strong GMP manufacturing experience within the life sciences sector and will play a key role in supporting site-wide Computer Systems Validation (CSV) and IT compliance activities.
This role provides IT compliance and validation support to the AIT team and the wider site, ensuring ongoing compliance with CSV, SDLC, Cyber Security, and Data Integrity requirements in support of the manufacture and supply of high-quality pharmaceutical products.
Key Responsibilities Ensure compliance with global SDLC, CSV, and IT Security policies and procedures.
Deliver all required compliance activities through effective planning, coordination, and execution of project and operational deliverables.
Support and manage compliance processes including: Change control Periodic reviews System performance monitoring System and access administration Disaster recovery activities Deviations, incidents, investigations, and CAPAs Audits and inspection readiness Cyber security and data integrity initiatives EHS and training compliance Operate in accordance with the Quality Management System (QMS), ensuring adherence to: Chapter 14 (Computer Systems)EU Annex 1121 CFR Part 11 MHRA (UK) GMP Data Integrity Guidelines Requirements Degree qualification in Science, Engineering, or a related technical discipline.3–5 years' Gx P experience in Computer Systems Validation within the life sciences, pharmaceutical, or medical device industry.
Proven ability to work effectively within high-performing, cross-functional teams.
Comfortable engaging with stakeholders at all levels in a fast-paced, dynamic environment.
Strong collaboration and leadership skills, with a focus on continuous improvement and best-practice implementation.
Excellent verbal and written communication, along with strong project management capabilities.
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