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Sr. Process Development Engineer– Combination Products & Device Engineer at Amgen

Setup
Hybrid
Location
New Albany, Ohio
Type
Full-time
Level
senior
Posted

Description

Amgen is hiring a Sr. Process Development Engineer– Combination Products & Device Engineer to serve as the technical leader and subject matter expert for combination products, auto-injectors, drug delivery devices, and automated assembly technologies at the Amgen Ohio site. The role leads process development, technology transfer, equipment implementation, validation, regulatory compliance, manufacturing support, continuous improvement, and complex cross-functional projects, while traveling up to 20% domestically and internationally. Candidates need a doctorate or an equivalent combination of degree and GMP-regulated engineering or operations experience, along with expertise in medical device and combination product regulations, design controls, statistical engineering, equipment qualification, and project leadership.

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