Sr. Process Development Engineer - Combination Products & Devices

About the role

The Sr. Process Development Engineer reports to the Associate Director of Process Development and acts as technical leader and subject matter expert for combination products, drug delivery devices and automated assembly technologies supporting commercial Combination Product and Final Drug Product operations at the Amgen Ohio site. The role covers development, commercialization, technology transfer, lifecycle management and continuous improvement of auto-injectors and other combination products, working in a cross-functional environment.

Key responsibilities

• Serve as site SME for combination products, auto-injectors and device assembly technologies, leading development, implementation and optimization of automated and semi-automated assembly equipment.
• Support product commercialization, design transfer and technology transfer into commercial manufacturing, and analyze engineering and manufacturing data to evaluate product performance and process capability.
• Provide technical support for device assembly, labeling, packaging, scale-up and product launches, and characterize equipment and processes to improve throughput, quality and reliability.
• Travel up to 20% domestically and internationally for projects, technology transfer, equipment suppliers and manufacturing sites.
• Lead product verification, characterization and performance testing, and author technical leadership for regulatory submissions, Design History File documentation and quality records.
• Lead root cause investigations and oversee deviations, change controls and CAPAs.
• Manage project scope, schedule, deliverables, risks, budgets and resources, and collaborate with Process Development, Manufacturing, Quality, Regulatory Affairs, Device Engineering and external partners.
• Lead continuous improvement initiatives, troubleshooting and statistical tools such as DOE, SPC, capability analysis and FMEA, and mentor engineers.

Required profile

• Doctorate degree, or Master's degree with 2 years of engineering/operations experience in a GMP-regulated environment, or Bachelor's degree with 4 years, or Associate's degree with 8 years.
• Experience in a GMP-regulated environment.