CSV Engineer - Limerick, Ireland - 12+ Month ContractI am currently looking for an experienced CSV Engineer who is interested in working for one of the leading companies in the Biopharmaceutical sector. This is a fantastic opportunity to join a hard-working team and work on a long term project in the pharma sector.Location: Limerick, IrelandPositions Available: 1Type: Contract (12+ Months)ResponsibilitiesDevelop and execute validation strategies for GxP computerized systems, including manufacturing automation, laboratory instrumentation, and enterprise applications.Ensure compliance with Data Integrity (DI) requirements and regulatory guidelines (FDA, EMA, HPRA, MHRA).Author, review, and approve CSV documentation, including Validation Plans, URS, FS, DS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports.Perform gap assessments and remediation of data integrity issues for existing automation and control systems.Validate automation systems such as SCADA, DCS, BMS, MES, and PLC-based controls in accordance with GAMP 5.Support change control processes, deviations, and CAPAs related to computerized systems.Conduct periodic reviews and revalidations of systems to ensure ongoing compliance.Collaborate with IT and Automation teams to implement and maintain cybersecurity measures for validated systems.Participate in regulatory audits and inspections, providing validation evidence and support.Develop and deliver training for internal teams on CSV and Data Integrity principles.Support the integration of Industry 4.0/5.0 concepts, AI-driven automation, and digital transformation strategies.RequirementsBachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or a related field.5+ years of experience in Computer System Validation within the pharmaceutical, biotech, or medical device industry.Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity principles.Experience with automation systems such as SCADA, DCS, BMS, MES, and PLC controls.Hands-on experience with validation of laboratory and enterprise systems (LIMS, Empower, SAP, Trackwise, LabWare).Proficiency in writing validation documentation and executing validation test scripts.
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