Senior Process & Device Engineer – Combination Products (Hybrid/Remote)

Biopharma Careers; New Albany (IN); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen is seeking a Sr. Process Development Engineer–Combination Products & Device Engineer at our Ohio site.

You will serve as a technical SME for combination products, drug delivery devices, and automated assembly technologies supporting commercial operations, driving development, technology transfer, and lifecycle management. Working in a cross-functional environment, you will lead device engineering initiatives, support manufacturing scale-up, validation, and regulatory compliance while

Qualifications

• PhD or equivalent with GMP/regulatory experience.
• Experience with combination product assembly equipment.
• Knowledge of ISO 13485 and FDA Part 820 regulations.
• Proven cross‑functional project leadership.

Responsibilities

• Lead site SME for combination products and auto-injectors.
• Oversee equipment validation, tech transfer, and process optimization.
• Coordinate with Device Eng, Manufacturing, QA and Regulatory teams.
• Drive continuous improvement and CAPA activities.

Skills

Cross-functional collaboration

Project leadership

DOE/SPC

Statistical methods

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

SolidWorks

CAD

Engineering drawings

Job description

Amgen is seeking a Sr. Process Development Engineer–Combination Products & Device Engineer at our Ohio site.

You will serve as a technical SME for combination products, drug delivery devices, and automated assembly technologies supporting commercial operations, driving development, technology transfer, and lifecycle management. Working in a cross-functional environment, you will lead device engineering initiatives, support manufacturing scale-up, validation, and regulatory compliance while