IT Labs CSV Engineer - Next Generation Biotech Manufacturing On behalf of our client who is an cutting-edge biotech manufacturing facility based in Raheen, Limerick, constructing a state-of-the-art manufacturing site with advanced technologies and innovative data collection platforms. Our mission is to deliver breakthrough improvements in safety, quality, and productivity.
The Role: Join our dynamic team as an IT Labs CSV Engineer and play a critical role in shaping the future of biotech manufacturing technology. This is an opportunity to work at the forefront of technological innovation in a greenfield manufacturing environment.
Location: Raheen, Limerick (Full-time on-site)
Key Responsibilities: Ensure computerized instrument systems comply with regulatory requirementsDevelop deep technical knowledge of laboratory IT equipmentProvide technical oversight for computer system validation (CSV) processesManage computer system validation projects and deliverablesLiaise with vendors to design and integrate instrument solutionsLead instrument upgrades and improvement projectsResolve system problems using advanced data analysisSupport audit activities and represent the site at corporate forumsEssential Requirements: Bachelor's Degree (Level 8) in IT, Computer Science, Engineering5+ years experience in biotech/pharmaceutical environmentsExtensive computer system validation experienceProven administration of computerized lab equipmentStrong troubleshooting and software understanding skillsDeep knowledge of regulatory requirements (21CFR Part 11)Excellent leadership and communication abilitiesPreferred Skills: Knowledge of IT infrastructure platformsProject management experienceExpertise in laboratory IT systems (Empower, Lab Vantage)Familiarity with Agile methodologiesWe Offer: Cutting-edge technological environmentOpportunity to drive innovationProfessional developmentCollaborative team cultureCompetitive compensation packageIf you're passionate about technology and want to make a significant impact in biotech manufacturing, we want to hear from you!
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