CSV Engineer

Computer Systems Validation (CSV) Engineer | Cork

Our client, a leading life sciences manufacturer, is seeking a CSV Engineer to support the validation of MES and other GMP-regulated computerised systems within a manufacturing environment.

Key Responsibilitie

• sAuthor, review and execute CSV documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols and summary reports
• .Support validation activities for MES, automation and manufacturing systems
• .Ensure compliance with GAMP 5, 21 CFR Part 11, Annex 11 and Data Integrity requirements
• .Manage deviations, CAPAs and change controls
• .Collaborate with QA, IT, Automation, Engineering and Operations teams

. Requiremen

• tsExperience in Computer Systems Validation (CSV) within a pharmaceutical, biotech or medical device environmen
• t.Strong understanding of GMP regulations and validation lifecycle activitie
• s.Experience with MES, SCADA, PLC or automation systems is highly desirabl
• e.Knowledge of GAMP 5, 21 CFR Part 11 and Annex 1