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 reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Job Posting Title

Principal Engineer

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead our Upstream Process engineering team at our new Single Use Facility at the Rhode Island Site. The Principal Engineer will lead a team focused on bioprocess cell culture process optimization, drug substance manufacturing support and new product introductions. The site operates two multiproduct facilities that manufacture a range of innovative biologic and biosimilar medicines. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility.

Responsibilities include:

• Supervise a team of Process Development Engineers focused on upstream cell culture processes
• Collaborate with Plant Managers, i.e., Production Managers and Senior Process Development staff to assess needs and update progress.
• Perform work that involves in-depth investigation of subject area
• Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity.
• Plan, prioritize and coordinate work of a staff of engineers and/or technicians.
• Lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility or process modifications.
• Designs, executes, implements, and directs engineering or process projects which significantly contribute to attaining high priority goals.
• Interpretation of Processes Characterization:
• Establish Testing Strategies
• Design / Development of Characterization Protocols
• Technical Reports Development
• Validations, and technical reports- support SATs executions, document generation and challenge validations strategies.
• Risk assessments and QRAES knowledge, to support risk assessments activities

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a strong communicator with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of Engineering and/or Operations experience OR
• Master’s degree and 6 years of Engineering and/or Operations experience OR
• Bachelor’s degree and 8 years of Engineering and/or Operations experience
• Associate’s degree and 10 years of Engineering and/or Operations experience OR
• High school diploma/GED and 12 years of Engineering and/or Operations experience

Preferred Qualifications (Engineer)

• 8+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing
• Proven ability to lead and deliver results in a highly fluid, interactive matrixed environment
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Background working with commercial manufacture of biologics using single use technology
• Strong understanding cGMP requirements
• Knowledge of regulatory filings and inspections
• Upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including technical support for nonconformance investigations and other commercial support activities
• Experience working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for biological molecules
• Deep understanding of operational aspects of biopharma and/or engineering industries
• Ability to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
• Skills in analysis of data generated using different analytical techniques
• Strong oral and verbal communication and presentation skills enabling strong relationships with internal and external partners
• Ability to derive insightful strategies to improve business processes
• Experience in supervision of direct reports and mentoring of matrix-team member.

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