This job has expired

You will need to login before you can apply for a job.

Engineer - Physical Methods

Employer
Amgen
Location
Thousand Oaks, CA
Start date
Aug 12, 2022
You need to sign in or create an account to save a job.

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

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 spectacularly improve peoples lives.

The Engineer, in Physical Methods, is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging parts. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key experienced support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.

Responsibilities

  • Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.

  • Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.

  • Develop, qualify, validate, and transfer new equipment, software, systems, and methods.

  • Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.

  • Provide experienced support for investigations as well as new process development required to improve manufacturing operations.

  • Coordinate test method development and delivery with selected contractors.

  • Ensure that qualification parameters are met for product assembly 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 process equipment.

  • Provide experienced training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or 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).

  • Generate/author and be responsible for the Test Method documents.

  • Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design

  • Perform other duties as required by the Group Manager

  • Align with the requirements, responsibilities, and authority as required

  • Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work

  • Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects

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

  • Drives the multi-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle

  • Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership

  • Collaborates with other functional leaders to ensure project success, momentum and commitment

  • Proactively identifies issues and/or risks and develops mitigation options to resolve or increase 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 container closure integrity methods into their processes.

Basic Qualifications

  • Master's Degree

  • OR Bachelor's Degree and 2 years of engineering/scientific experience

  • OR Associate's degree and 6 years of engineering/scientific experience

  • OR High school diploma/GED and 8 years of engineering/scientific experience.

Preferred Qualifications

  • M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry

  • Excellent written and verbal communication skills

  • Ability to work in a highly matrixed team environment

  • 2 years of experience in the biotechnology/pharmaceutical industry

  • 2 years of experience in equipment, method, and mechanical design

  • Technical writing experience

  • Experience with SolidWorks (or other 3D-CAD software)

  • Experience with combination products and regulatory requirements

  • Experience applying Minitab (or other statistical software packages)

  • 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, so we work to care for our teammates professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and improve 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.

FacebookTwitter

Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert