Senior CSV Automation Engineer

As a Senior CSV Engineer, you will lead the development, review, and execution of automation-related validation documentation and activities. You’ll collaborate closely with cross-functional SMEs, equipment vendors, and quality teams to ensure compliance with regulatory standards and project timelines.

• Identifying risks and recommending improvements to validation strategies and documentation quality.
• Executing CSV-related tests on equipment and production lines.
• Leading the authoring and management of key validation documents: C&Q Plans, PCS Automation Validation Plans, URS, FAT, IOQ, Summary Reports.
• Overseeing and supporting FAT and IOQ execution, ensuring alignment with test scripts and resolving protocol execution issues.
• Ensuring compliance with 21 CFR Part 11, EudraLex Annex 11, and GAMP 5.
• Sharing lessons learned and contributing to continuous improvement for future projects.
• Maintaining traceability across all validation documentation (URS, FAT, SAT, IOQ, RTM, etc.).

• Strong understanding of computer systems and PLC automation systems.
• Degree in Computer Science, Engineering, or a related discipline.
• Experience with paperless validation systems (e.g., Kneat) is a plus.
• Minimum 3 years’ experience in a similar role within the life sciences sector, ideally in pharmaceutical manufacturing.
• Familiarity with GMP environments and validation processes aligned with EU and FDA regulations.
• Strong problem-solving, communication, and documentation skills.
• Expertise in GAMP 5 and SDLC documentation (URS, FS, DS, RTM, etc.).
• Experience with systems such as MES, PI Data Historian, PCS, Lab Systems, QBMS, and Inspection Line Control Systems.
• Eligibility: Applicants must have the right to work in Ireland. Sponsorship is not available for this role.
• Proven experience authoring and executing FAT and IOQ protocols.
• Ability to collaborate with QA, vendors, and cross-functional teams to ensure project success.