Amgen Engineer - Final Product Technology in Thousand Oaks, California
The Engineer position reports into Final Product Technology in Thousand Oaks. This position requires the application of engineering principles (mechanical and materials science), as well as excellent project management and communication skills.
The position may require travel to domestic and international locations, primarily to support the technical transfer of primary components to fill/finish facilities. Less than 5% travel expected.
Key areas of this Engineer role:
Evaluate and characterize new and existing primary container platforms
Qualify new primary container platforms
Update User Requirement Specifications of primary container closure systems for new and existing Amgen products
Provide hands-on technical support for primary component issues related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals
Support development of characterization methods for mechanical and physical properties of primary components
Support integration of primary containers into new and existing devices
Support on-going NC/CAPAs and Change Control
Collaborate extensively with internal and external project teams, i.e. manufacturing, vendors, quality, regulatory, etc.
This role will leverage project management skills and the ability to coordinate and communicate across different functions and sites to successfully complete projects.
Bachelor's degree and 2 years of Engineering or related experience
Associate's degree and 6 years of Engineering or related experience
High school diploma / GED and 8 years of Engineering or related experience
M.S. or Ph. D. in Engineering or Lifesciences with 2+ years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry.
Strong team-work, excellent interpersonal and communication skills
Strong capability of scientific/engineering/laboratory analysis, troubleshooting and ability to apply advanced problem-solving skills within defined constraints
Ability to develop and follow detailed protocols
Knowledge of aseptic fill-finish operations and glass container characteristics highly desirable
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.