Summary: Our client, a leading biopharmaceutical company based in East Cork, has an opportunity for a CSV Engineer to join their team.
This role will focus primarily on the rollout of MES Electronic Batch Records (EBR), while also supporting a number of smaller validation projects.
The successful candidate will ensure all activities are performed in compliance with GAMP5, data integrity, and regulatory standards.
Responsibilities: Lead and support the rollout of MES Electronic Batch Records (EBR) in alignment with site validation strategies and cGMP requirements.
Plan, execute, and maintain validation deliverables in accordance with GAMP5 and site procedures.
Prepare, review, and approve key documentation, including User Requirements Specifications (URS), Validation Plans, Test Protocols, and Summary Reports.
Collaborate with cross-functional teams, including Manufacturing, Automation, IT, and Quality, to ensure efficient and compliant validation project delivery.
Participate in change control, deviation management, and periodic review processes related to computerised systems.
Provide support and input into smaller CSV projects across the site.
Ensure all CSV activities are traceable and maintained in accordance with Data Integrity and site documentation practices.
Support the use of Kneat validation software for document lifecycle management.
Qualifications & Experience: Degree in Engineering, Computer Science, or a related technical discipline.
Minimum of 3 years experience in a similar role and environment Proven experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical or biopharmaceutical environments.
Strong working knowledge of MES systems and Electronic Batch Record (EBR) implementation.
Familiarity with Kneat validation software is an advantage.
Comprehensive understanding of GAMP5, 21 CFR Part 11, Annex 11, and Data Integrity principles.