Sr. Process Development Engineer– Combination Products & Device Engineer

Summary

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.

Job description

Requirements

• Doctorate degree OR Master’s degree and 2 years of Engineering/Operation in GMP regulated environment experience
• Bachelor’s degree and 4 years of Engineering/Operation in GMP regulated environment experience
• Associate’s degree and 8 years of Engineering/Operation in GMP regulated environment experience
• High school diploma / GED and 10 years of Engineering/Operation in GMP regulated environment experience
• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or another engineering or science-related discipline
• Experience supporting manufacturing, operations, process development, device engineering, or combination product development within a regulated industry
• Experience in the development, commercialization, lifecycle management, and manufacturing support of medical devices, combination products, drug delivery systems, auto-injectors, prefilled syringes, or related technologies
• Demonstrated expertise with combination product assembly equipment, automated and semi-automated manufacturing systems, and applicable product testing methodologies
• Strong understanding of medical device and combination product regulations, including FDA QSR (21 CFR Part 820), Combination Product Regulations (21 CFR Part 4), ISO 13485, ISO 14971, EU MDR 2017/745, and applicable ASTM, ISO, and compendial standards
• Working knowledge of Design Controls, including Design Planning, Design Verification, Design Validation, Design Transfer, Design History Files (DHF), and Risk Management
• Experience supporting device assembly, final drug product (FDP) manufacturing, labeling, packaging operations, technology transfer, process validation, and commercial manufacturing
• Experience leading commissioning, qualification, and validation (CQV) of manufacturing equipment and supporting GMP manufacturing operations
• Demonstrated experience working with device, equipment, and component suppliers to support equipment design, qualification, technology transfer, and commercialization
• Proficiency with CAD software (SolidWorks preferred), engineering drawings, assemblies, and technical documentation
• Experience applying statistical engineering tools including Design of Experiments (DOE), Statistical Process Control (SPC), capability analysis, data trending, and engineering data analysis
• Demonstrated expertise in structured problem solving, root cause analysis, risk assessments, Failure Mode and Effects Analysis (FMEA), and implementation of corrective and preventive actions (CAPA)
• Proven track record of leading complex cross-functional engineering projects from concept through commercialization while managing multiple priorities, timelines, and technical deliverables
• Excellent project management, organizational, and technical leadership skills with the ability to influence decisions across a matrix organization
• Exceptional written, verbal, and technical communication skills, including experience authoring engineering documentation, validation protocols, technical reports, and regulatory submissions
• Strong interpersonal skills with the ability to collaborate effectively across Process Development, Device Engineering, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external partners
• Demonstrated ability to work independently, adapt to changing business priorities, and thrive in a fast-paced, highly regulated manufacturing environment
• Passion for Operational Excellence, continuous improvement, innovation, and mentoring others while fostering a collaborative, patient-focused culture

Benefits

• Retirement and Savings Plan
• Medical, Dental & Vision
• Life and Disability Insurance
• Flexible Spending Accounts
• Annual Bonus Program
• Stock-based Long-term Incentives
• Paid Time Off
• Flexible Work Models

Company overview

Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.