Amgen

Principal Engineer - FPT SRE Technical Lead

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 21, 2019
Ref
R-78405
Required Education
High School or equivalent
Position Type
Full time
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

The Principal Engineer position reports into the Director of Process Engineering, Commercial Advancement under Final Product Technologies. This position requires knowledge of glass forming, molding/processing of polymers and elastomers, thermal and stress analysis, surface treatments, particle reduction, extractables/leachables, mechanical properties and industry (supplier) best practices, project management skills, and the ability to coordinate and communicate across different functions and sites/cultures in order to successfully complete projects.

The position travels to international locations, assisting our primary component design and development projects, approximately 25% of overall time for travel is expected.

Job Responsibilities include:
  • Lead the design control process and qualification of primary components
  • Lead the integration of primary containers into new and existing devices
  • Develop specifications of primary container closure systems for new and existing Amgen products
  • Apply diverse and advanced engineering and scientific principles (mechanical and materials science)
  • Support the development and operational improvements with key primary component suppliers
  • Support development of characterization methods for mechanical and physical properties of primary components
  • Support on-going Nonconformance/CAPA and Change Control
  • Collaborate extensively with internal and external project teams, i.e.
    manufacturing, suppliers, quality, regulatory, etc.
  • Drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences


Basic Qualifications

Doctorate degree & 2 years of Engineering experience

OR

Master's degree & 6 years of Engineering experience

OR

Bachelor's degree or & 8 years of Engineering experience

OR

Associate's degree & 10 years of Engineering experience

OR

High school diploma / GED & 12 years of Engineering experience

Preferred Qualifications
  • Doctorate in Mechanical, Biomedical Engineering, Polymer Engineering or Materials Science with 5+ years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry.
  • Direct experience with the manufacturing process (glass/elastomers/polymers) for medical (aseptic) applications.
  • Direct experience of aseptic fill & finish operations.
  • Excellent written and verbal communication skills together with demonstrated ability to work in a team environment both within Amgen and with our suppliers.
  • Proven track record of leading and executing cross-functional projects.
  • Ability to work in a highly regulated and industry.
  • Experience in forensics analytical techniques and equipment.
  • Ability to learn and rapidly adapt to new requirements in a fast moving environment.
  • An Operational Excellence approach to work product - driving rapid results.
  • A passion to deliver excellent work product.


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.