Amgen

Engineer - Final Product Technologies

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 22, 2019
Ref
R-78635
Required Education
Bachelors Degree
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.

This position reports into the Container Science and Engineering department within Design and Development Group under Final Drug Product Technology in Thousand Oaks. The position requires the application of engineering principles to successfully perform the job functions.

Job Responsibilities include:
  • Support senior staff in the initiation, design, and delivery of projects, particularly in primary container design, characterization, and qualification
  • Leverage technical skills and the ability to coordinate and communicate across different functions to successfully complete projects
  • Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution
  • Assist with project definition by performing engineering studies and assessment for drug delivery systems
  • Perform field evaluations of existing systems and provide engineering design recommendations
  • Design and development of primary container systems
  • Design and development of physical test methods with respect to container and combination product integration of drug delivery systems
  • Capable of machine design from initial conception through fabrication and into implementation
  • Provide detailed data analysis to enable senior staff to make informed decisions
  • Assist with project definition by performing engineering studies/assessments for device and container characterization/qualification in a GMP environment.
  • Investigate and develop new processes required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving)
  • Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget
  • 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
  • Work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost


Basic Qualifications

Master's Degree

OR

Bachelor's Degree and 2 years of Engineering experience

OR

Associate's degree and 6 years of Engineering experience

OR

High school diploma/GED and 8 years of Engineering experience

Preferred Qualifications
  • Masters degree in Mechanical/Biomedical Engineering
  • Strong team work, interpersonal and communication skills
  • 2+ years of experience in the biotechnology/pharmaceutical industry
  • 2+ years of experience in equipment, method, and mechanical design
  • Strong mechanical engineering and material science knowledge
  • Previous intern experience is a plus.
  • Experience with mechanical machine design is a plus.
  • Experience with theoretical physics based modeling
  • Proficiency in Solidworks
  • Experience with combination products and regulatory requirements
  • Strong oral and written communication skills
  • Experience with computer programming in Matlab
  • Strong technical writing skills


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.