Sr. Process Development Engineer Combination Products & Device Engineer
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Benefits offered by this job
Job summary
Amgen Ohio is seeking a Sr. Process Development Engineer to lead combination product and device engineering efforts, including technology transfer and lifecycle management for auto-injectors and related systems.
You will provide technical leadership for process development, equipment validation, and cross‑functional collaboration to ensure compliant, scalable commercial operations.
Qualifications
- Doctorate or advanced degree with GMP/regulated environment experience.
- Experience supporting device assembly, FDP manufacturing, and regulatory documentation.
- Familiarity with design controls and quality systems for medical devices.
Responsibilities
- Oversee development, technology transfer, and lifecycle management of combination products and auto-injectors.
- Lead equipment validation, testing, and regulatory documentation for commercial operations.
- Guide cross-functional teams across Process Development, Manufacturing, Quality, and Regulatory Affairs.
- Drive continuous improvement to improve throughput, quality, and process capability.
- Coordinate with suppliers for equipment qualification and technology transfer.
Skills
Education
Tools
Job description
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.
Oversee the development, commercialization, technology transfer, lifecycle management, and continuous improvement of auto‑injectors and other combination products in a highly collaborative cross‑functional environment.
Provide technical leadership for process development, technology transfer, equipment implementation, and manufacturing support to ensure safe, reliable, and compliant commercial operations.
- 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 as required.
Provide engineering expertise throughout the equipment and product lifecycle from concept and qualification through commercial manufacturing. Ensure compliance with design controls, GMP requirements, and global regulatory standards while resolving complex technical challenges.
- 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.
Lead complex technical projects and collaborate across the Amgen network to successfully deliver innovative device and manufacturing solutions.
- 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.
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.
- 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.
The process development professional we seek will possess the following qualifications.
- Doctorate degree
- Or Masters degree and 2 years of Engineering/Operation in a GMP regulated environment
- Or Bachelors degree and 4 years of Engineering/Operation in a GMP regulated environment
- Or Associates degree and 8 years of Engineering/Operation in a GMP regulated environment
- Or High school diploma / GED and 10 years of Engineering/Operation in a GMP regulated environment
- 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 DOE, SPC, capability analysis, data trending, and engineering data analysis.
- Demonstrated expertise in structured problem solving, root cause analysis, risk assessments, 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.
From competitive benefits to a collaborative culture, we support your professional and personal growth and well‑being.
- 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.
- 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.
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.
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