Associate Mfg Systems Engineer I
Amgen · Holly Springs, NC
IT & SoftwareFull-timeCompany career page
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Role summary
Associate Manufacturing Systems Engineer I will serve as a technical lead for validation strategy development and implementation at Amgen's North Carolina manufacturing facility. The role encompasses creating validation documentation, supporting equipment qualification and cleaning validation activities, and coordinating across multiple departments to ensure compliance with manufacturing standards.
What they're looking for
- High school diploma/GED plus 6 years manufacturing or operations experience, or Associate's degree plus 4 years experience, or Bachelor's degree
- Technical writing and presentation skills for cross-functional collaboration
- Experience with validation protocols, equipment qualification, and cleaning validation in biologics
- Ability to read P&IDs and manage multiple concurrent projects
- Proficiency in systems such as Kneat, CDOCs, Laboratory Inventory Management System, or Pi preferred
What you'll be doing
- Develop and generate validation documentation including Validation Master Plan, qualification protocols, and related reports
- Lead commissioning, qualification, cleaning/sterilization validation, and maintenance support activities at the facility
- Generate, review, and approve cleaning validation documents such as characterization and acceptance limits reports
- Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development teams on validation requirements
- Support site validation-driven continuous improvement initiatives
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.