Sr. Process Development Engineer– Combination Products & Device Engineer

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

Role: Senior Process Development Engineer specializing in combination products and drug delivery devices, supporting commercial manufacturing at Amgen's Ohio site. Objectives: lead device engineering, process development, technology transfer, lifecycle management, and continuous improvement of auto-injectors and related combination products.

Responsibilities

• serve as site SME for device assembly, optimize automated manufacturing equipment, support product commercialization and transfer, develop engineering studies, and ensure regulatory compliance.
• Lead validation efforts and provide technical leadership across project cycles, including troubleshooting, root cause analysis, and risk management.
• Collaborate with internal teams and external vendors to support equipment qualification and process scalability.
• Drive operational excellence through data-driven process optimization, process validation, and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Manufacturing, Chemical Engineering, or related field with 4+ years GMP experience; or advanced degrees with proportionate experience.
• Preferred skills include expertise in medical device manufacturing, combination product regulations (FDA, ISO standards, EU MDR), device design, validation, and technical documentation.
• Experience with CAD tools, statistical engineering methods, and cross-functional project management is essential.

High-value specifics

• focus on combination products, drug delivery devices (auto-injectors), lifecycle management, regulated environment (GMP, QSR), and supporting global compliance standards.

Role involves up to 20% domestic and international travel. Work setup: on-site with potential hybrid flexibility.