We are seeking a senior CSV Engineer (minimum 10 years' experience) to lead and deliver major computer system validation initiatives within a regulated medical device environment; candidates with strong pharma or biotech experience will also be considered. This role requires full ownership of CSV projects, including defining validation strategy, authoring and executing validation documentation (URS, RA, IQ/OQ/PQ), managing system change control, and ensuring compliance with applicable regulatory standards. The consultant will drive delivery of new system implementations, upgrades, and periodic reviews, as well as lead investigations, remediation activities, and cross-functional alignment on quality and compliance expectations. The ideal candidate has a proven track record of delivering complex validation programs, influencing stakeholders, and ensuring systems remain audit-ready. Position is onsite in Cork, with the option to work from home on Fridays.