Principal Engineer - Operations Core Content Lead

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Principal Engineer - Operations Core Content Lead (CCL)

Live

What you will do

Let's do this. Let's change the world. . In this vital role you will be part of Amgen's Final Product Technologies (FPT) Organization where you will be accountable to define strategic boundaries (core content) for platform technologies and advance overall platform execution strategy as part of Amgen's efforts to expand our platform-based approach to product development. The CCL will represent FPT and Operations in gathering input of key partners across the organization, determining core content, and in determining key business processes for its implementation. The CCL will provide expert mentorship to product teams on platform strategies. The CCL will give voice and drive awareness to the generation and application of the core content.

• Lead establishment of platform strategic boundaries for final product presentations, including drug delivery device, package and label, and container technologies
• Drive awareness and adoption of the boundary framework across all platforms
• Manage ongoing improvement of the core content to match the evolving needs of portfolio
• Provide mentorship to product programs moving through platform governance
• Lead / drive assessment of change impact and fit-to-platform against boundaries
• Budget responsibility and other program assignments as applicable

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineer we seek is successful and multi-functional collaborator with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Life Sciences Engineering experience

OR

Master's degree and 6 years of Life Sciences Engineering experience

OR

Bachelor's degree and 8 years of Life Sciences Engineering experience

OR

Associate's degree and 10 years of Life Sciences Engineering experience

OR

High school diploma / GED and 12 years of Life Sciences Engineering experience

Preferred Qualifications:

• Master's Degree or PhD in Mechanical, Electrical, Systems, Materials, Biomedical or similar technical field
• 10+ years of demonstrated experience in drug / device combination product or drug delivery development with broad exposure to HW/SW/ Systems design and technical depth in a technical field
• 5+ years of leadership experience in development, research, or manufacturing environment
• Product design/development (design control) from concept to post product launch for Europe (EU MDR/CE Mark) & US submissions
• Capable of concurrently working on different projects in a deadline driven environment
• Demonstrated ability to partner with technical leadership team to implement product platform/subsystem multi-generation technology plan for a global program/product
• Strong background in detailing requirements and specification for regulatory approval
• Demonstrated strength in execution of product verification and validation, Design of Experiments (DOE)/SPC, process optimization & validation (IQ, OQ, PQ), Failure Mode Effects Analysis (FMEA)
• INCOSE certification or formal Systems Engineering training/certification
• Proficient experience driving Critical to Quality (CTQ) hierarchical decomposition (flow-down) to subsystems and components
• Experience in platform-based system design and architecture
• Strong oral and written communications
• Experience in addressing and resolving system level architecture design trade-offs, tolerance/performance analysis, etc.
• Robust knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations
• Practical experience in configuration management and change control process/requirements - CCB (change control board), CIT (change implementation team) concepts
• Prior experience in management of contract resources
• Experience in leading continuous improvement activities
• Strong interpersonal skills
• Familiar with the following standards: US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); Needle-based Injection Systems (ISO 11608-1); Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601)

Thrive

What you can expect of us

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.

• 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.