CSV Engineer (456)

Réalta Technologies are searching for a CSV Engineer to support our Pharmaceutical client based in Dublin.

The CSV Engineer will be responsible for leading the development, review, and delivery of automation-related documentation and validation activities. The role requires close collaboration with cross-functional SMEs, equipment vendors, and quality teams to ensure compliance with regulatory standards, project timelines, and operational requirements

Job Responsibilities

• Authoring and managing the following (with input from SMEs): C&Q Plan & Risk assessments, Automation Validation Plans, URS documentation / Data Integrity Assessment/ System Impact Assessment / RTMs, FAT/SAT documentation, IOQ documentation and Summary Reports.
• Monitor FAT/SAT and IOQ execution activities, proactively identifying protocol execution issues and providing solutions.
• Ensure FAT/SAT and IOQ execution aligns with the intent of the test scripts.
• Executing tests on lines, systems and equipment that are CSV related.
• Ensure all automation deliverables comply with applicable regulations and industry best-practice guidance such as 21 CFR Part 11, EudraLex Annex 11, and GAMP 5.
• Maintain consistency and traceability across C&Q Plans, Automation Plans, URS, FAT, SAT, IOQ, STQM/RTM, and Summary Reports.
• Identify risks and propose improvements to the C&Q and automation qualification strategy, documentation quality, and test execution strategy.
• Share lessons learned and contribute to knowledge transfer for future projects.

Job Requirements

• Relevant Computer Science or Engineering degree or equivalent
• Minimum of 6 years' experience in a similar role in life sciences, ideally in pharmaceutical manufacturing.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the
  E.U. and U.S. FDA.
• Expert knowledge of GAMP5.
• Strong experience in one or all the following systems: MES, PI Data Historian, PCS, Lab Systems, QBMS, Inspection Line Control Systems, Filling Lines.
• Solid technical understanding of computer systems and PLC automation systems, enabling FAT and IOQ protocols to be
  authored with support from other SMEs.
• Ability to manage multiple deliverables and coordinate with cross-functional resources.
• Ability to develop templates for all SDLC deliverables, compliant with client standards, to ensure consistent implementation of the validation strategy, including but not limited to: Requirements Specification, Requirements Traceability Matrix, Functional Specification, Data Integrity Assessments, Design Specification, Code Review and Test specification/test script.
• Experienced tester of FAT and IOQ test scripts
• Strong interpersonal and communication skills (verbal and written).
• Previous experience working with paperless validation system Kneat will be advantageous