Senior Process Development Engineer – Auto-Injectors & Combo Devices

Amgen; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen's Ohio site seeks a Senior Process Development Engineer focused on combination products and auto-injectors. You will lead device engineering, process development, technology transfer, lifecycle management, and ongoing improvements of drug delivery devices in a GMP environment.

You collaborate across functions to optimize automated manufacturing, support commercialization, validate processes, and drive continuous improvement while ensuring regulatory compliance and global standards.

Qualifications

• BS in engineering with 4+ years GMP experience
• Experience in medical device manufacturing and regulatory standards (FDA/ISO)
• Proficient with CAD, statistics, and documentation practices

Responsibilities

• Serve as site SME for device assembly and optimize automated manufacturing equipment
• Lead validation efforts and provide technical leadership across project cycles
• Collaborate with internal teams and external vendors for equipment qualification and process scalability
• Drive operational excellence through data-driven process optimization and continuous improvement initiatives

Skills

Regulatory compliance

Cross-functional project management

Root cause analysis

Data-driven decision making

Education

Bachelor's degree in Mechanical, Biomedical, Manufacturing, Chemical Engineering, or related field

Tools

CAD tools

Statistical engineering methods

Process validation

Job description

Amgen's Ohio site seeks a Senior Process Development Engineer focused on combination products and auto-injectors. You will lead device engineering, process development, technology transfer, lifecycle management, and ongoing improvements of drug delivery devices in a GMP environment.

You collaborate across functions to optimize automated manufacturing, support commercialization, validate processes, and drive continuous improvement while ensuring regulatory compliance and global standards.