IT Specialist III, GMP Systems

Role: IT Specialist III supporting GMP Manufacturing Systems in a biotech setting, focusing on deployment, support, and validation of GxP systems within a regulated environment. Responsibilities: manage end-user devices, configure and support GMP systems, serve as System Owner for Manufacturing IT applications, ensure GMP compliance through system upgrades and validation per CSV processes, author validation documents, and collaborate with vendors. Requirements: Bachelor’s degree or equivalent in Computer Science or related field; 5+ years supporting manufacturing-critical systems in biotech or pharma; experience as a System Owner for validated GxP systems; knowledge of Data Integrity, GMP regulations (21 CFR Part 11, Annex 11), and related standards; familiarity with manufacturing systems like MES, LIMS, ERP. High-Value: biopharma manufacturing, GxP validation, GMP compliance, data integrity principles, regulated environment. WorkSetup: onsite in Redmond, WA; travel not specified.