Amgen

Engineer - Final Product Technologies

Employer
Amgen
Location
Juncos, PR
Posted
Sep 18, 2021
Ref
R-126240
Required Education
Bachelors Degree
Position Type
Full time

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.

Engineer - Final Product Technologies

Live

What you will do

Lets do this. Lets change the world. In this vital role you will lead tech transfer activities for FDP supporting characterization, process optimization, and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment, work with cross-functional teams to support the Commercialization of Amgen products around the globe as well as the life cycle support of all commercial products. To effectively serve patients, we build effective tech transfer plan for our combination products that enhance end to end controls with robust methods with data flow to our digital infrastructure in a GMP setting.

Specific responsibilities include but are not limited to:
  • Lead tech transfer activities for FDP
  • Support NPI to Amgen sites or CMOs
  • Own documentation such as Project Plan, PTD (Process Transfer Document), Protocols and reports
  • Lead M-a-B (Make-a-Batch) activities to make sure the sending/receiving sites expectation are met
  • Lead the KT analysis exercise in case of new equipment required
  • Provide project dashboard updates
  • Provide communication plan to Process Engineer management

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineer - Final Product Technologies professional we seek is an individual contributor with these qualifications.

The Basic Qualifications are:

Masters degree in engineering

OR

Bachelors Degree in engineering and two years engineering experience

Beyond that the additional preferred qualifications are:

  • Educational Background in Mechanical, Electrical or Chemical Engineering
  • Experience in a Combination Product field with a focus on manufacturing
  • Experience and knowledge of interdependencies of Combination Products and Final Drug Product
  • Knowledge of Combination Product design controls and Regulatory requirements on a global scale
  • Understanding of Amgen commercialization framework
  • Program and Project Management skills
  • Knowledge and experience in risk assessment, management and mitigation
  • Change Management Skills
  • Strong project management skills
  • Ability to apply engineering science to production
  • Strong teamwork, excellent interpersonal and communication skills

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 maximize 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

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.

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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.

Amgen requires all staff in the United States and Puerto Rico 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.