Sr. Process Development Engineer– Combination Products & Device Engineer

Sr. Process Development Engineer– Combination Products & Device Engineer

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

Let's do this. Let's change the world. In this role, the Sr. Process Development Engineer reports to the Associate Director of Process Development and serves as the technical leader and Subject Matter Expert (SME) for combination products, drug delivery devices, and automated assembly technologies supporting commercial Combination Product and Final Drug Product (FDP) operations at the Amgen Ohio site.

This position combines advanced device engineering expertise with process development leadership to support the development, commercialization, technology transfer, lifecycle management, and continuous improvement of auto-injectors and other combination products. Working in a highly collaborative cross-functional environment, you will lead initiatives spanning device engineering, manufacturing process development, equipment implementation, validation, and regulatory compliance to ensure reliable, compliant, and efficient commercial manufacturing.

Process Development & Manufacturing Support

The Sr. Engineer applies advanced engineering and scientific principles to support the development, commercialization, and lifecycle management of combination products and manufacturing technologies. This role provides technical leadership for process development, technology transfer, equipment implementation, and manufacturing support to ensure safe, reliable, and compliant commercial operations.

Key Responsibilities

• Serve as the site Subject Matter Expert (SME) for combination products, auto-injectors, and device assembly technologies.
• Lead the development, implementation, and optimization of automated and semi-automated combination product assembly equipment.
• Support product commercialization, design transfer, and technology transfer into commercial manufacturing.
• Develop and execute engineering studies, characterization plans, test methods, protocols, and reports supporting product development and manufacturing.
• Analyze engineering and manufacturing data to evaluate product performance, process capability, and manufacturing robustness.
• Provide technical support for device assembly, labeling, packaging, manufacturing scale-up, and commercial product launches.
• Characterize manufacturing equipment/processes and implement engineering solutions to improve throughput, quality, equipment reliability, and operational efficiency.
• Travel up to 20% domestically and internationally as required to support project execution, technology transfer, equipment suppliers, and manufacturing sites.

Technical Leadership & Equipment Validation

As the technical leader for device assembly technologies, you will provide engineering expertise throughout the equipment and product lifecycle—from concept and qualification through commercial manufacturing. This role ensures compliance with design controls, GMP requirements, and global regulatory standards while resolving complex technical challenges.

Key Responsibilities

• Lead product verification, characterization, and…