Validation Engineer I
Amgen · Holly Springs, NC
QualityFull-timeCompany career page
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Role summary
Amgen seeks a Validation Engineer I to serve as technical lead and subject matter expert for validation strategy at the North Carolina manufacturing facility. The role encompasses development of validation documentation, equipment qualification, cleaning validation, and coordination across manufacturing, engineering, and quality functions.
What they're looking for
- High school diploma/GED plus 8 years manufacturing or operations experience
- Associate's degree plus 6 years manufacturing or operations experience
- Bachelor's degree plus 2 years manufacturing or operations experience
- Strong written and verbal communication skills with ability to work independently
- Equipment qualification and cleaning validation experience in biologics facility
- Project management experience managing multiple concurrent priorities
What you'll be doing
- Develop and implement validation strategy including master plans, protocols, and qualification reports at facility
- Provide technical expertise for equipment commissioning, qualification, and cleaning/sterilization validation activities
- Generate and review cleaning validation documents including characterization studies and acceptance limits
- Coordinate with manufacturing, engineering, quality, and process development to meet Amgen validation requirements
- Conduct root cause analysis and support corrective/preventive actions for operational issues and deviations
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.