Sr. Process Engineer

Thousand Oaks, CA, US
Oct 28, 2020
Required Education
Bachelors Degree
Position Type
Full time
Amgen is seeking a Sr. Process Engineer to join the B7 Next Gen. Process Owners team at our Amgen Thousand Oaks (ATO) facilities. We enable Amgen's mission to serve patients by supporting robust processes and innovative technologies using our scientific and engineering expertise.

The role will provide technical support to complex engineering equipment and processes. Experience in design, qualification, operation, maintenance and improvement of biopharmaceutical equipment and processes will be required to support day to day manufacturing activities as well as to lead improvement projects. The candidate will partner with manufacturing, quality, supply chain, equipment engineering and process scientists to produce clinical supply and work toward commercial facility licensure.

Job Responsibilities:
  • Applies advanced and diverse science and engineering principles to the design and implementation of major system modifications, process and/or capital projects.
  • Support and provide technical expertise on clinical and commercial tech transfers of late stage Amgen products from laboratories and across manufacturing facilities
  • Own cell culture and purification drug substance processes
  • Develops, organizes, analyses and presents interpretation of results for operational issues of significant scope and complexity
  • Equipment / Process expertise to perform complex troubleshooting of process, equipment failures or malfunctions and/or the development of technical assessments
  • Perform process monitoring, assess process impact, and provide technical troubleshooting using sophisticated digital tools
  • Strong knowledge on Biopharmaceutical operations and processes such as single use technologies, Media / Buffer Prep solutions, Inoculation, Bioreactors, Harvest, Chromatography and Tangential Flow Filtration
  • Provide technical expertise/guidance and lead investigations for process related deviations, change control and operational excellence projects
  • Demonstrate project management skills and application of concepts.
  • Experience in investigation of deviations, development of corrective and preventive actions and generation and implementation of change controls.

Basic Qualifications:
  • Master's degree and 2 year of Process Engineering experience

  • Bachelor's degree and 5 years of Process Engineering experience

  • Associates degree and 8 years Process Engineering experience

  • High school diploma / GED and 10 years Process Engineering experience

Preferred Qualifications:
  • Degree in Chemical/Biochemical Engineering
  • 5+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of biologics (cGMP)
  • Demonstrated leadership skills and decision-making experience
  • Background in biologics tech transfer into commercial facilities
  • Knowledge of cell culture and purification processes/ equipment
  • Strong academic and applied experience in science and engineering, troubleshooting, and problem solving
  • Independently motivated with successful ability to multi-task and work in teams
  • Excellent written and verbal communication with experience with technical writing and presentations
  • Process optimization and change control experience.

Amgen is committed and dedicated to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Come join us!

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.