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Sr Engineer

Employer
Amgen
Location
Thousand Oaks, California
Start date
Jun 2, 2024

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr Engineer

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

Responsibilities:
  • Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
  • Implement projects per CPO (Combination Product Operations) and company procedures to ensure projects are completed on schedule and within established budget.
  • Apply core engineering principles to develop physical test methods for medical device and combination product systems.
  • Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
  • Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
  • Coordinate gauge and equipment development and delivery with selected contractors.
  • Ensure that qualification parameters are met for product assembly and performance requirements.
  • Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
  • Generate procedures necessary to support department and new product equipment.

The position will require approximately 10% travel to international locations assisting our development partners during implementation of mechanical engineering methods into their processes.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 2 years of Engineering experience

Or

Bachelors degree and 4 years of Engineering experience

Or

Associates degree and 8 years of Engineering experience

Or

High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications:

  • M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
  • Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
  • Experience with managing technical teams, including setting priorities and leveling resources
  • Technical writing experience
  • Spanish language skills preferred
  • Experienced with SolidWorks (or other 3D-CAD software)
  • Familiar with equipment and software IOQ
  • Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
  • Experience with change controls, deviations, CAPA
  • Experience with combination products and device regulatory requirements
  • Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
  • Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

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

careers.amgen.com

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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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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