Sr. Process Development Engineer Combination Products & Device Engineer

Join Amgen Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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. 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 Masters degree and 2 years of Engineering/Operation in GMP regulated environment experience Or Bachelors degree and 4 years of Engineering/Operation in GMP regulated environment experience Or Associates degree and 8 years of Engineering/Operation in GMP regulated environment experience Or High school diploma / GED and 10 years of Engineering/Operation in GMP regulated environment experience Preferred Qualifications 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 Quality System Regulation (21 CFR Part 820) Combination Product Regulations (21 CFR Part 4) ISO 13485 Quality Management Systems for Medical Devices ISO 14971 Risk Management for Medical Devices EU Medical Device Regulation (EU MDR 2017/745) 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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr BioSpace