Senior Process Dev Engineer - Combo Products & Devices

BioSpace

New Albany (OH)

On-site

USD 120,000 - 180,000

Full time

36 hours ago

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Job summary

Amgen Ohio is seeking a Sr. Process Development Engineer for combination products and device engineering. You will lead development, technology transfer, and manufacturing support for medical devices and FDP, ensuring GMP compliance and design controls.

The role requires deep expertise in process development, product verification, regulatory documentation, and cross-functional collaboration across Process Development, Manufacturing, Quality, Regulatory Affairs, and suppliers.

Qualifications

Doctorate or equivalent combination of education and experience in GMP/regulatory environment.
Bachelor's or Master’s with 2+ years GMP experience or equivalent.
Experience with device assembly, FDP manufacturing, labeling, packaging operations and technology transfer.

Responsibilities

Lead product verification, characterization, and performance testing to demonstrate product safety, functionality, and design robustness.
Translate user needs into technical documentation and engineering deliverables.
Author and provide technical leadership for regulatory submissions and quality records.
Lead root cause investigations and CAPA implementation.
Support equipment lifecycle management and continuous process verification.
Coordinate activities with internal teams and external partners for equipment implementation.