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Senior Engineer - Physical Testing Systems Development

Employer
Amgen
Location
Thousand Oaks, CA
Start date
Sep 21, 2022
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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.

Senior Engineer - Physical Testing Systems Development

The Senior Engineer is 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.

Live

What you will do

Lets do this. Lets change the world.

  • 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 FPT (Final Product Technologies) 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 process 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 vital to support department and new product equipment.

  • Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).

  • Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.

  • Excellent communication (written and verbal) and organizational skills

  • Develops and maintains integrated timelines collecting appropriate multi-functional details and deliverables which are aligned with the functional and project deliverables

  • Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen

  • Facilitates robust horizontal communication to ensure all functions are aware of changes in work and impacts to risk.

  • Proactively identifies issues and/or risks and develops mitigation options to resolve or raise efficiently

  • Integrates partner/vendor timelines with Amgen timelines as appropriate

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 outstanding contributions to serve patients.

Basic Qualifications:

  • Doctorate Degree OR

  • Master's Degree and 3 years of Engineering experience OR

  • Bachelor's Degree and 5 years of Engineering experience OR

  • Associate's degree and 10 years of Engineering experience OR

  • High school diploma/GED and 12 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, using 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

  • Experience with machine controls (PLC, HMI) and vision systems

Thrive

Some of the vast rewards of working here

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.

  • Full support and career-development resources to expand your skills, improve your expertise, and maximize your potential along your career journey

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

  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear. 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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