Amgen

Engineer - Final Product Technology/Commercial Product

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 10, 2019
Ref
R-79035
Required Education
Bachelors Degree
Position Type
Full time
Amgen is a science based biotechnology pioneer. Our innovative human therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve new patients.

This Engineer position reports into Final Product Technologies (FPT), Commercial Advancement organization. This role is an Individual contributor with Leadership attributes to effectively represent FPT engineer within a large network/matrix organization. We are seeking a competent engineer in all conventional aspects of the subject matter, functional area, and assignments. The position requires the application of engineering principles (materials science and mechanical), as well as excellent project management and communication skills. The engineer will participate in the lifecycle management related activities for the design of commercial primary containers and drug delivery devices. This includes technical support for manufacturing operations, failure investigation, design changes, test procedures development, scale-up and global launch, supplier development, and continuous improvement. The incumbent shall have capability and competency of working with multiple project teams at the same time, as well as ability to learn and self-develop expertise in the assigned areas of technology. The position will focus on engineering assignments focused on commercial primary containers, mechanical, electro-mechanical systems, and fluid-mechanical systems. The qualified candidate will be part of a Commercial Product Engineering team that ensures successful final product design transfers and sustainability of related components.

This position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.

Job Responsibilities include:
  • Conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
  • Provide hands-on technical support for any primary containers topics as well as for aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals.
  • Maintain technical records within design history file associated with assigned products.
  • Generate and maintain design specification, write protocol & report, generate prototype, conduct DOE/SPC for product optimization, perform design verification & validation, conduct FMEA, etc.
  • Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
  • Support Deviation, CAPA and Change Control.
  • Work with scientists and engineers internally and externally to assess and improve design and manufacturing specifications.


Basic Qualifications

Master's degree
OR
Bachelor's degree and 2 years of Engineering or Operations experience

OR
Associate's degree and 6 years of Engineering or Operations experience
OR
High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications
  • Ph. D. in Engineering or Lifesciences
  • 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.