Principal Engineer (NPI, Tech Transfer) (R-143370)
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.
What you will do
Let’s do this. Let’s change the world. As a member of the Amgen Ohio, Process Development organization, this role serves as project manager and technical expert for Final Drug Product Tech Transfers and New Process Introductions (NPI) into Amgen Ohio. Tech Transfers and NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.
The Principal Engineer engages Drug Product development teams throughout the clinical/commercialization process, leading multi-functional teams with support from Manufacturing, Supply Chain, Quality, Engineering, Process Development and other business groups.
Primary responsibilities include assessment of Tech Transfers and NPI’s for necessary process, facility, equipment, materials, and training modifications; development of project implementation plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/oversight of Tech Transfers and NPI activities, which may include project management, document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities.Specific job activities may include the following:
- Work with various Tech Transfers and NPI support groups to develop, maintain, and implement the Tech Transfers and NPI project plan. Principal Engineer will function as the Tech Transfers and NPI project manager and is accountable for project scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and partner concern to different levels of management as appropriate.
- Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks.
- Facilitate the development and optimization of Tech Transfers and NPI business processes. As applicable, serve as a representative on various global network teams or network-sponsored initiatives to advance the Final Drug Product operational practices and technologies.
- Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the Tech Transfers and NPI.
- Support generation, revision, review, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications). Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies.
- Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.
Doctorate degree and 2 years of Engineering, Scientific, or Biotech experienceOr
Master’s degree and 6 years of Engineering, Scientific, or Biotech experienceOr
Bachelor’s degree and 8 years of Engineering, Scientific, or Biotech experienceOr
Associate’s degree and 10 years of Engineering, Scientific, or Biotech experience
High school diploma / GED and 12 years of Engineering, Scientific, or Biotech experienceThrive
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
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.[Register to View]
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.