Amgen

Sr Commercial Product Engineer

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 11, 2020
Ref
R-104124
Required Education
High School or equivalent
Position Type
Full time
Do you want to help craft the future of biopharmaceutical manufacturing? Are you excited by the challenge of a diverse product portfolio of life changing products, in a dynamic working environment?

If you enjoy working with a highly motivated and driven team of process science professionals to positively impact patients' lives, come join us!

We are seeking a Senior Commercial Product Engineer who will be instrumental in the design development and lifecycle management-related activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up and global launch, supplier development, and continuous improvement. Scope includes mechanical and electro-mechanical delivery devices, such as: fluid transfer devices, automatic pen injectors, reusable automatic injectors, or micro-infuser delivery pump systems.

Our Sr. Commercial Product Engineer will be a key part of a sustaining device engineering team that ensures design history files of these systems are maintained. The engineer will participate in multi-functional teams, leading device design activities such as developing product improvements, supporting new development project teams, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.

Responsibilities:
  • Applying all conventional aspects of the subject matter, functional area, and their assignments. Planning and conducting work requiring judgment in the independent review, selection, and relevant adaptation and modification of standard engineering techniques, procedures and criteria and devises innovative ways to problems encountered.
  • Accountable for maintaining technical records within design history file associated with assigned products.
  • Supporting system level design, development, and V&V work for commercial lifecycle management changes or in support of new project development
  • Developing test methods, generating and maintaining design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
  • Leading system level root cause investigation, coordinating design improvements with development partners, tactical planning and driving design changes and improvements.
  • Working with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications
  • Performing as an individual contributor with leadership attributes to efficiency, and represent device engineering within a large network/matrix organization
  • The position is located in Thousand Oaks, CA and requires 10% or less, domestic (and possible international) travel.

Basic Qualifications:

Doctorate Degree
Or

Master's Degree and 2 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment
Or

Bachelor's Degree and 4 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment
Or

Associate's degree and 10 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment
Or

High school diploma/GED and 12 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment

Preferred Qualifications:
  • Master's degree in biomedical/mechanical/electrical or related Engineering field and 5+ years of related engineering experience
  • A background in development and commercialization of medical devices and knowledge of manufacturing processes
  • Systems Engineering design experience and thinking, driving user needs to craft requirements to verified and validated final product outputs
  • Strong understanding and experience in design controls, failure investigation, initiating and bringing sophisticated projects to conclusion
  • Familiar with the following standards and regulations: Quality System Regulation - 21CFR820, Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC
  • Ability to work independently and across functional teams
  • Excellent (technical) written and verbal communication


Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.

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.

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.