Associate Mfg Systems Engineer I

Role: Associate Manufacturing Systems Engineer I, serving as a technical lead and SME for validation strategies at Amgen’s North Carolina facility. Responsibilities: develop and execute validation master plans, protocols, and reports; support commissioning, equipment qualification, cleaning and sterilization validation, and validation maintenance; collaborate across Manufacturing, Engineering, Quality, Supply Chain, and Process Development; drive validation process improvements. Requirements: high school diploma/GED with 6 years or associate’s degree with 4 years of manufacturing/operations experience, or a bachelor’s degree. Preferred skills: technical writing, experience with Kneat, CDOCs, Laboratory Inventory Management, sample management lifecycle; ability to learn equipment qualification, cleaning validation, autoclaves, and process validation; familiarity with P&IDs, validation protocols, and reports. High-value biopharma specifics: role supports biologics manufacturing validation, including sterilization and equipment qualification, at a biologics-focused facility. No explicit location or travel details provided.