Sr. Process Development Engineer– Combination Products & Device Engineer

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.