Sr. Process Development Engineer– Combination Products & Device Engineer

Job description

Career CategoryProcess DevelopmentJob DescriptionJoin 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. Sr. Process Development Engineer– Combination Products & Device Engineer 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 performance testing to demonstrate product safety, functionality, and design robustness. Translate user needs and design requirements into technical documentation, manufacturing specifications, and engineering deliverables. Author and provide technical leadership for regulatory submissions, technical reports, Design History File documentation, and quality records. Lead root cause investigations and provide technical oversight for deviations, change controls, CAPAs, and implementation of sustainable corrective actions. Support equipment lifecycle management, process monitoring, and continuous process verification while coordinating technical activities with internal engineering teams and equipment suppliers. Project Leadership & Cross-Functional Collaboration The Sr. Engineer leads complex technical projects and collaborates across the Amgen network to successfully deliver innovative device and manufacturing solutions. This role provides technical direction, manages project execution, and builds strong partnerships with internal and external stakeholders. Key Responsibilities Site SME collaborating with cross-functional engineering teams supporting combination product and device technology programs. Manage project scope, schedules, technical deliverables, risks, budgets, and resource planning. Provide technical leadership across Process Development, Manufacturing, Quality, Regulatory Affairs, Device Engineering, and external partners. Coordinate technical activities with equipment suppliers and development partners to support equipment implementation, component qualification, and commercialization. Communicate project status, technical recommendations, and business impacts to leadership and key stakeholders. Build technical partnerships across Amgen's commercial manufacturing network to leverage best practices, standardize manufacturing approaches, and support future product introductions. Operational Excellence & Continuous Improvement The Sr. Engineer champions Operational Excellence by applying data-driven engineering principles to improve manufacturing performance, equipment reliability, product quality, and process capability. This role identifies and implements sustainable improvements that enhance operational efficiency and reduce manufacturing risk. Key Responsibilities Lead continuous improvement initiatives for device assembly, packaging, and manufacturing operations. Troubleshoot complex manufacturing and equipment issues using structured engineering and statistical problem-solving methodologies. Apply statistical tools including Design of Experiments (DOE), Statistical Process Control (SPC), capability analysis, and data trending to optimize process performance. Support risk assessments, Failure Mode and Effects Analysis (FMEA), and process optimization activities to improve product quality and manufacturing robustness. Develop standardized engineering practices, equipment strategies, and technical solutions that improve productivity, capacity, and operational performance across the manufacturing network. Mentor engineers and contribute to the development of technical capabilities and engineering best practices. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The process development professional we seek will possess these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of Engineering/Operation in GMP regulated environment experience Or Bachelor’s degree and 4 years of Engineering/Operation in GMP regulated environment experience Or Associate’s degree and 8 years of Engineering/Operation in GMP regulated environment experience Or High school diploma / GED and 10 years of Engineering/Ope