Sr. Process Development Engineer– Combination Products & Device Engineer

Amgen · New Albany, OH

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What they're looking for

Advanced device engineering expertise with process development leadership experience
Subject matter expertise in combination products, auto-injectors, or drug delivery devices
Experience leading equipment implementation, validation, and manufacturing scale-up
Proficiency with design controls, GMP requirements, and regulatory compliance standards
Strong project management and cross-functional team leadership capabilities
Experience with root cause analysis, CAPA implementation, and process optimization

What you'll be doing

Serve as site subject matter expert for combination products and automated assembly technologies
Lead development, implementation, and optimization of automated product assembly equipment
Support product commercialization, design transfer, and technology transfer into manufacturing
Develop engineering studies, test methods, and protocols to support product development
Lead root cause investigations and provide oversight for deviations and corrective actions

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RoleLantern checked active

RoleLantern checkedNeeds clarity

Date posted4 days ago

Last source check1 day ago

Salary listedNeeds clarity

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