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Csv engineer

Carlow
Impact Engineering
Engineer
Posted: 20 December
Offer description

Role OverviewImpact Engineering is currently recruiting an experiencedCSV Engineer(3–5 years' experience preferred) to join the CSV team at aclient site in Carlow.The successful candidate will bring strongGMP manufacturing experiencewithin the life sciences sector and will play a key role in supporting site-wideComputer Systems Validation (CSV)and IT compliance activities.This role providesIT compliance and validation supportto the AIT team and the wider site, ensuring ongoing compliance withCSV, SDLC, Cyber Security, and Data Integrity requirementsin support of the manufacture and supply of high-quality pharmaceutical products.Key ResponsibilitiesEnsure 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 controlPeriodic reviewsSystem performance monitoringSystem and access administrationDisaster recovery activitiesDeviations, incidents, investigations, and CAPAsAudits and inspection readinessPolicy deploymentCyber security and data integrity initiativesEHS and training complianceOperate in accordance with the Quality Management System (QMS), ensuring adherence to:Chapter 14 (Computer Systems)EU Annex 1121 CFR Part 11MHRA (UK) GMP Data Integrity GuidelinesSarbanes-Oxley (SOX) requirementsRequirementsDegree qualification in Science, Engineering, or a related technical discipline .3–5 years' GxP 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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