Summary: A CSV Engineer is required to support a biopharmaceutical manufacturing environment in West Dublin.
The successful candidate will be responsible for delivering CSV activities across technical projects, ensuring compliance with cGMP, data integrity, and regulatory requirements.
The ideal candidate will provide independent quality oversight of system lifecycle documentation for GxP systems, including automated equipment, DCS, MES, and associated infrastructure, while working closely with Engineering, Automation, Quality, and Operations teams to support project delivery and site operations.
Responsibilities: Act as a Computer System Validation Subject Matter Expert (SME) for systems supporting GMP manufacturing, including MES, DCS, and automated equipment Prepare, review, and approve CSV lifecycle documentation, including validation plans, user requirements, risk assessments, protocols, reports, and summary documentation Support the development and execution of CSV strategies for new and existing computerised systems, applying risk-based and leveraged validation approaches Ensure CSV activities comply with applicable regulations and guidelines, including cGMP, GAMP 5, Annex 11, and 21 CFR Part 11 Provide proactive CSV support to project teams to ensure validation activities align with project timelines Participate in validation risk assessments to define appropriate levels of testing for new or modified systems Review equipment specifications, design documentation, installation records, and qualification documentation Support validation activities across manufacturing, packaging, and laboratory areas Generate, manage, and resolve validation deviations, discrepancies, and documentation issues Support investigations and assess potential data integrity risks arising during validation or routine operations Perform periodic reviews of computerised systems and identify any compliance gaps Contribute to the development and maintenance of Qualification and Validation SOPs Support regulatory inspections and internal audits related to computerised systems Work closely with local and global CSV teams to ensure consistency and alignment across projects Escalate potential compliance or quality risks in a timely and appropriate manner Promote safe working practices and adherence to site EHS requirements Support commissioning and validation activities in compliance with site safety procedures Qualifications & Experience: Degree in Engineering, Life Sciences, Computer Science, or a related technical discipline preferred Minimum 5 to 7 years experience in Computer System Validation or a related technical role within a regulated biopharmaceutical or life sciences environment Strong understanding of current quality and regulatory requirements for computerised systems Hands-on experience validating GAMP Category 3, 4, and 5 systems Proven experience executing validation protocols, managing validation data, and ensuring data integrity In-depth knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines Experience supporting investigations, root cause analysis, and corrective actions related to validation or data integrity issues