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 c GMP, data integrity, and regulatory requirements.
The ideal candidate will provide independent quality oversight of system lifecycle documentation for Gx P 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 c GMP, 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
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
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