Sr. Process Development Engineer– Combination Products & Device Engineer

Overview

Join Amgen’s Mission of Serving Patients. As part of the global team, you will help advance a broad pipeline of medicines that treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity‑related conditions. The work is driven by our commitment to improving patients’ lives.

The Sr. Process Development Engineer – Combination Products & Device Engineer reports to the Associate Director of Process Development and serves as 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 operations at the Amgen Ohio site.

• Serve as the site SME for combination products, auto‑injectors, and device assembly technologies.
• Lead 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 for project execution, technology transfer, equipment suppliers, and manufacturing sites.
• 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 sustainable corrective actions.
• Support equipment lifecycle management, process monitoring, and continuous process verification while coordinating with internal engineering teams and equipment suppliers.
• Manage project scope, schedules, technical deliverables, risks, budgets, and resources.
• Provide technical direction across Process Development, Manufacturing, Quality, Regulatory Affairs, Device Engineering, and external partners.
• Communicate project status, technical recommendations, and business impacts to leadership and key stakeholders.
• Build technical partnerships across Amgen’s commercial manufacturing network to standardize manufacturing approaches and support future product introductions.
• Champion Operational Excellence by applying data‑driven engineering principles to improve manufacturing performance, equipment reliability, product quality, and process capability.
• Lead continuous improvement initiatives for device assembly, packaging, and manufacturing operations.
• 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.
• Develop standardized engineering practices, equipment strategies, and technical solutions that enhance productivity, capacity, and operational performance across the manufacturing network.
• Mentor engineers and contribute to the development of technical capabilities and engineering best practices.

• Doctorate degree OR Master’s degree and 2 years of engineering/operation in a GMP regulated environment.
• Bachelor’s degree and 4 years of engineering/operation in a GMP regulated environment.
• Associate’s degree and 8 years of engineering/operation in a GMP regulated environment.
• High school diploma / GED and 10…