Sr. Process Development Engineer– Combination Products & Device Engineer

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives 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

Lets do this. Lets change the 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. Working in a highly collaborative cross-functional environment you will lead initiatives spanning device engineering manufacturing process development equipment implementation validation and regulatory compliance to ensure reliable compliant and efficient commercial manufacturing.

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 lifecyclefrom 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 Amgens 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:

• Bachelors or Masters 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 health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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

Apply now and make a lasting impact with the Amgen team.

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.

Salary Range