Senior Csv Automation Engineer
4 days ago
OverviewSenior CSV Automation Engineer - 12-Month Contract - Biopharmaceutical - Client-Side - Dublin - €1B Greenfield ProjectWe're excited to offer a fantastic opportunity for a Senior CSV Automation Engineer to join our client-side team on a 12-month rolling contract in Dublin.This role is part of a brand-new €1 billion greenfield Drug Product Facility project, currently in the early stages of construction, giving you the chance to be involved from the ground up, with an estimated 3 years of project scope ahead.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.ResponsibilitiesLeading 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.Executing CSV-related tests on equipment and production lines.Ensuring compliance with 21 CFR Part 11, EudraLex Annex 11, and GAMP 5.Maintaining traceability across all validation documentation (URS, FAT, SAT, IOQ, RTM, etc.).Identifying risks and recommending improvements to validation strategies and documentation quality.Sharing lessons learned and contributing to continuous improvement for future projects.RequirementsDegree in Computer Science, Engineering, or a related discipline.Minimum 3 years' experience in a similar role within the life sciences sector, ideally in pharmaceutical manufacturing.Strong understanding of computer systems and PLC automation systems.Proven experience authoring and executing FAT and IOQ protocols.Familiarity with GMP environments and validation processes aligned with EU and FDA regulations.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.Strong problem-solving, communication, and documentation skills.Experience with paperless validation systems (e.g., Kneat) is a plus.Ability to collaborate with QA, vendors, and cross-functional teams to ensure project success.Additional InformationLocation:Dublin, Ireland (Client-Site)Contract Type:12-Month Rolling ContractEligibility:Applicants must have the right to work in Ireland.Sponsorship is not available for this role.#J-*****-Ljbffr
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CSV Engineer
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