Principal Engineer

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.

Principal Engineer

Live

What you will do

Lets do this. Lets change the world. In this vital role you will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation, continuous process verification and general manufacturing support.

• Accountable for successfully implementing all site process development activities to enable clinical and commercial tech transfers of parenteral drug products to Amgens drug product manufacturing facility in Thousand Oaks
• Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support clinical and commercial drug product manufacturing operations with technical evaluation of deviations.
• Accountable for process validation of commercial products in alignment to applicable laws (FDA, EU & global standards) and required policies and procedures, including safety and training
• Communicate with manufacturing and other plant support functions (QA, engineering, regulatory) to implement process improvements
• Manage and supervise a team of tech transfer leads responsible to assess facility-to-process fit during make-a-batch exercise, ensure transferability of off-line characterization studies, design and implement on-site characterization studies and process validation runs, author/own high quality technical documents and regulatory files, provide on-site support and evaluate product impact due to process, scale, equipment and raw material changes.
• Accountable for building, owning and maturing business processes to manage NPI/tech transfer portfolio for all drug product commercial tech transfers to the Thousand Oaks manufacturing facility in a tactical, strategic and agile manner, ensuring successful project completion, and driving continuous improvement, increasing team productivity and efficient use of available resources, as demonstrated by performance metrics
• Build, maintain and improve tech transfer efficiency tools, including utilization of offline characterization capabilities and predictive models, development of templated documents, implementation of lessons learned and more.
• Build and own site assessment business process for new product introductions and represent the plant in engagement with the network and operations strategy planning teams
• Build and sustain excellent relationships with partners drug product teams, NPI, QA, Supply Chain, Process Development and manufacturing teams to ensure alignment between program needs and site capabilities
• Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as required, and support PAI, GMP inspections in the plant
• Participates in site selection to provide technical fit of new product process requirements to manufacturing capabilities and a realistic account of resources for tech transfer and manufacturing support post approval
• Deliver progress reports and presentations, including generation and upkeep of dashboards to ensure management is aware of status and progress. Escalate issues, recommendations on unresolved challenges in a professional and timely manner to the appropriate governance.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a a highly motivated Principal Engineer to provide process development support to Amgens clinical and commercial sterile fill-finish manufacturing plant with these qualifications.

Basic Qualifications:

• Doctorate degree & 2 years of Engineering or Process Development experience OR
• Masters degree & 6 years of Operations or Process Development experience OR
• Bachelors degree & 8 years of Operations or Process Development experience
• Associates degree and 10 years of experience OR
• High school diploma / GED and 12 years of experience

Preferred Qualifications:

• Advanced degree in engineering, biotechnology, life sciences or related field
• 5+ years of experience in the pharmaceutical or biotechnology industry in support of commercial drug product manufacturing that includes areas such as process development, process characterization, technical transfers and validation
• Strong skills in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
• Strong knowledge of Quality systems, drug product manufacturing (GMP) and Validation
• Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.
• Demonstrated ability in leading multi-functional teams to advance complex projects to completion and influencing decisions.
• Ability to lead innovation, collaborate in a multi-functional team environment, and act on dynamic information at a rapid pace
• Capable of organizing and communicating complex technical concepts to enable business decisions
• Demonstrated ability to use interpersonal skills to build strong technical relationships.
• Excellent communication skills, both oral and written.
• Ability to elevate relevant issues to project lead and line-management

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.