Specialist, Manufacturing – Production Process Owner
Amgen · Thousand Oaks, CA
Manufacturing OperationsFull-timeCompany career page
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Role summary
This role supports manufacturing operations in Drug Product at Amgen's Thousand Oaks site, focusing on deviation management, process compliance, and continuous improvement. The specialist will investigate manufacturing issues, manage documentation within GMP standards, and collaborate with cross-functional teams on process implementation and performance optimization.
What they're looking for
- Doctorate degree, or Master's degree with 2 years manufacturing experience
- Bachelor's degree with 4 years manufacturing experience, or Associate's with 8 years
- High school diploma/GED with 10 years manufacturing experience
- Experience in aseptic Drug Product or biologics manufacturing
- Knowledge of process validation, deviation management, and change control
- Proficiency with data visualization tools such as Spotfire, JMP, or Excel
- Strong written and verbal communication with cross-functional collaboration ability
What you'll be doing
- Support investigation and resolution of manufacturing deviations and participate in root cause analyses
- Initiate, revise, and approve controlled manufacturing documents in electronic systems ensuring GMP compliance
- Support implementation of new processes, equipment, and initiatives in Drug Product operations
- Analyze manufacturing data and metrics to identify trends and develop data-driven improvement solutions
- Assist in developing and executing process validation protocols and supporting change control activities
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.