Senior Engineer

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. 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.

Senior Engineer

What you will do

Lets do this. Lets change the world. In this vital role you will lead part of development, and lifecycle management of manufacturing processes for drug delivery drug/device combination products. This includes technical operations support for design control activities, device manufacturing, failure investigations, leading and assessing design changes impact to manufacturing, developing test procedures, leading scale-up and global launch, and continuous improvement. Responsibilities of this position may include:

• Lead process characterization of prefilled syringe delivery systems, including packaging, labeling, and accessories.
• Lead process improvements, conduct analytical failure analysis, and implement process solutions.
• Author technical records and ensure they are appropriately maintained in the e.g. Device Master record (DMR)/Master Manufacturing Record (MMR)
• Author technical content in Tech Transfer.
• Represent Process engineering within a large network/matrix organization.
• Evaluate test methods, prototype designs, and optimize products and processes using DOE and statistical techniques.
• Monitor project progress, identify risks, and implement mitigation strategies to ensure project landmarks and timelines are met.
• Key player in fostering a collaborative and innovative team environment to drive continuous improvement and operational excellence.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering and/or Operations experience; OR
• Associates degree and 8 years of Engineering and/or Operations experience; Or
• Bachelors degree and 4 years of Engineering and/or Operations experience; Or
• Masters degree and 2 years of Engineering and/or Operations experience; Or
• Doctorate degree

Preferred Qualifications:

• Bachelor's degree in engineering or other science-related field with 7+ years of relevant work experience with 5+ years of experience in operations/manufacturing environment.
• Medical device industry experience and regulated work environment experience.
• A background in developing and commercialization of medical devices and knowledge of manufacturing processes.
• At a minimum familiar with the following standards and regulations: Quality System Regulation 21CFR820, Risk Management ISO 14971, EU Medical Device requirements Council Directive 93/42/EEC.
• Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion.
• Excellent communication and technical writing skills.
• Ability to work independently and across functional teams.
• Strong inter-personal and communication skills, with the ability to effectively collaborate with diverse teams and partners.
• Extensive knowledge of design controls and regulatory requirements for medical devices and combination products.
• Background in Combination product manufacturing processes and knowledge of developing and commercializing medical devices.
• Familiarity with standards and regulations such as Quality System Regulation 21CFR820, Risk Management ISO 14971, and EU Medical Device requirements Council Directive 93/42/EEC.
• Strong understanding and experience in process failure investigation and project management.
• Preferably have technical flair and are familiar with technical drawings and construction.
• Demonstrated proficiency in project management.
• Preferably have Strong background in statistical analysis (experience with e.g. Minitab, JMP is an advantage)
• Preferably have experience with Kistler Maxymos monitoring systems.
• Strong problem-solving skills and the ability to make sound technical decisions
• Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.

What you can expect from 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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.