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Principal Engineer - Test Methods

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peoples lives.

Reporting to the Physical Science and Engineering team in the Combination Product Operations (CPO) group, the Principal Methods Engineer (PME), will lead a group of combination product test methods development engineers. The test methods developed in this team will support testing for design control characterization / verification. These test methods will go on to serve as manufacturing process controls throughout the Amgen Global Manufacturing network. The position will require roughly 20% travel (post Covid-19).

The successful PME candidate will have demonstrated multi-disciplinary and multi-functional product leadership experience. The PME will be responsible for supervising and coaching engineers though technical challenges in developing, characterizing, qualifying, validating and transferring methods that measure the electrical, mechanical and physical properties of primary containers, packaging components, mechanical drug delivery pens, and electromechanical autoinjectors. The PME will launch medium to long range projects to improve the test method process. Exposure to physical testing equipment is highly desirable. Group members within the functional area look up to this position as a scientific/technical expert who can provide guidance on associated issues as needed. The position needs demonstrated supervisory skills.

Principal Engineer - Test Methods

Live

What you will do

Lets do this. Lets change the world.

  • Owns and maintains compliant business processes for development, validation, transfer and lifecycle management of electrical, mechanical and physical test methods for manufacturing process control.

  • Manages the method lifecycle of released methods, including trending of methods metrics, pareto and root causing of methods issues at the manufacturing sites. Manages the CAPAs and Change Controls to fix them.

  • Transfers validated methods to incoming inspection, process monitoring, and product release labs across the Amgen Global Manufacturing network.

  • Ensures test methods validation, transfer, and lifecycle management documentation can withstand audits and pass regulatory agency scrutiny.

  • Ensures that automated test equipment development, programming, and validation can withstand audits and pass regulatory agency scrutiny.

  • Rapidly Design, develop and qualify and innovate automated inspection equipment for Amgen primary containers and devices to meet new and unique product requirements.

  • Owns and manages the process for creation and use of working Reference Standards for use within Amgens engineering and manufacturing groups

  • Advises others on methods to resolve measurement problems, current with information government and industrial standardization committees and professional societies

  • Manage projects, personnel, and laboratory through development of innovative solutions based on insightful interpretation and analysis of the problem statement or investigation

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

  • Doctorate degree and 2 years of engineering experience OR

  • Masters degree and 6 years of engineering experience OR

  • Bachelors degree and 8 years of engineering experience OR

  • Associates degree and 10 years of engineering experience OR

  • High school diploma / GED and 12 years of engineering experience

Preferred Qualifications:

  • 8+ years of experience in the testing industry with 3+ years of test development, test equipment / test method validation, and manufacturing support of test methods.

  • 3+ years experience in leading teams of lean a lean, hard-working multi-disciplinary and multi-functional technical staff.

  • Experience working with physical testing equipment such as Instron, Zwick, or optical microscopes.

  • Ability to communicate technical material to executive management teams in a clear and concise manner, in a style understood by management, for the purposes of procuring project authorization.

  • Experience translating the needs of multi-functional groups (manufacturing, quality, marketing, regulatory, legal, supply chain) into actionable ideas and tasks for engineering and management teams.

  • Experience participating and presenting in regulatory agency audits regarding testing subject matter.

  • Excellent problem solving, trouble shooting, and communication skills. Ability to participate in global multi-functional teams and work effectively in a highly matrixed team environment with constantly evolving challenges

  • Demonstrated proficiencies skills and proven track record of leading multi-functional projects, ability to mentor junior engineers, strong teamwork, excellent interpersonal and communication skills

  • Solid Works engineering drawing, statistical study design, DOE, and DFM tool sets (Six sigma is highly desired).

  • Experience with MS Office Suite, MS SharePoint, MS Project, Minitab/JMP, SolidWorks, LabView, and PLC controller software.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization

  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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