Sr. Process Development Engineer– Combination Products & Device Engineer

About the Position

Sr. Process Development Engineer– Combination Products & Device Engineer

US - Ohio - New Albany

Join 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.

Responsibilities

Process Development & Manufacturing Support

• 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

• 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

• 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

• 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.

Requirements

Basic Qualifications:

• Doctorate degree
• 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

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.

We Offer

• Competitive salary range: $115,494.60 - $156,257.40 USD
• 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
• Opportunities for professional and personal growth

About the Company

Amgen is a global biotechnology company that has been dedicated to serving patients since 1980. We are focused on the development of innovative medicines to treat serious illnesses, including cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. Our commitment to scientific excellence and patient care drives our mission to deliver life-changing treatments to millions of patients worldwide.