Process Development Engineer
Amgen
Full-time
Remote friendly (Thousand Oaks, CA)
Worldwide
Operations
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Process Development Engineer
Company Name: Amgen
Job Overview
The Process Development Engineer at Amgen is responsible for commercial process validations and ensuring excellence in technology transfers for parenteral drug products.
Key Responsibilities:
- Leading new product introductions
- Designing and documenting process characterization studies
- Authoring technical transfer documents
- Ensuring compliance with regulatory standards (FDA, EU, global)
- Providing expertise in aseptic processing, process characterization, tech transfer, and validation
- Supporting manufacturing operations
- Collaborating with cross-functional teams
Requirements:
- A Master's degree or equivalent engineering experience is required.