Principal Engineer - ATO F&E Drug Substance Plant Engineering

Thousand Oaks, CA, US
Oct 14, 2019
Required Education
High School or equivalent
Position Type
Full time
As a member of the Facility and Engineering (F&E) organization at the Amgen Thousand Oaks (ATO) site, this Principal Engineer will be a technical and people leader in support of the ATO Drug Substance Supply (DSS) operations in B23 and B30. The DSS function manufactures both clinical and commercial drug substance via a wide range of processes using both traditional and new technologies. The successful applicant will provide technical leadership with respect to the process equipment, development of new projects, and development of this functions' capabilities. The applicant will also manage a team of Senior Engineers, Engineers, and/or External Workers who own systems, support operations, execute capital projects, and participate in larger construction capital projects. The applicant should have proven experience effectively leading and developing a team and a strong technical background. This leader must also partner effectively with the automation, maintenance, manufacturing, EHS, and QA functions. This position reports directly to the Engineering Senior Manager responsible for the DSS Engineering organization of F&E and will have direct reports.

Specific responsibilities include:
  • Ensure safety of all personnel during plant operations and engineering activities
  • Ensure equipment performs as validated to produce lots per the production schedule
  • Maintain and improve plant capability and capacity per forecasted demands
  • Improve equipment reliability in partnership with manufacturing, maintenance, and QA
  • Manage a portfolio of equipment and facility projects and deliver results as planned
  • Partner with the Global Capital Project Management function to deliver large capital investments
  • Identify areas of potential improvement, analyze solutions, advise decisions, sponsor improvement projects, and implement as required
  • Represent Plant Engineering in internal/external audits and inspections
  • Deploy new technologies as improve reliability as needed for deployment in the network
  • Manage a portfolio of small and large capital projects, develop options, and obtain funding
  • Leverage the engineering expertise at Amgen and share innovations and improvements

Basic Qualifications:

Doctorate degree and 2 years of Engineering experience
Master's degree and 6 years of Engineering experience
Bachelor's degree and 8 years of Engineering experience
Associate's degree and 10 years of Engineering experience
High school diploma / GED and 12 years of Engineering experience

Preferred Qualifications
  • Bachelor's degree in Engineering (Chemical or Mechanical), Biotechnology
  • 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
  • Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
  • Design and troubleshooting experience in a GMP Biopharmaceutical Production facility with systems such as traditional and single use bioreactors, chromatography systems, UFDF, and viral filtration equipment and the utilities needed to support these processes such as autoclaves, cleaning systems, washers, clean steam, water for injection, etc.
  • Experience executing capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation.
  • Strong organizational and supervisory skills
  • Demonstrated analytical and problem-solving skills
  • Excellent communication and interpersonal skills
  • Proven track record of delivering results against specific goals
  • Strong decision-making skills using a rigorous process
  • Ability to use continuous improvement tools to drive countermeasures and projects
  • Knowledge of biopharmaceutical processes and facilities and the associated regulations
  • Experience in external agency audits answering complex requests
  • Effective technical writing and presentation skills
  • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
  • Up to 10% domestic/international travel

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.