Amgen Engineer - Commercial Product Engineering in Thousand Oaks, California
Amgen is seeking an Engineer - Commercial Product Engineering at its main headquarters in Thousand Oaks, CA to join the Commercial Advancement organization within Process Development.
The Commercial Product Engineering team is the point of accountability for the portfolio of final product presentations for commercialized product. With this the Global Design Center responsible to manage technical / design files related to final product presentation (Device, Packaging, Primary and Secondary Containers).
Key Activities of the Commercial Product Engineering team include the lead/support of follow-on product launches, manufacturing scale-ups, and site-to-site design transfers. Lead/support design related variation management and post-launch expansions. Management of final product specification and platform configurations. The support of technical investigations driven from complaints, manufacturing quality defects, supplier/CMO assessments.
Within this engineering role you will own the (Secondary) Packaging aspects of the Commercial Product Engineering process. You are an Industry Expert: Utilize knowledge on pharmaceutical packaging and assembly equipment, process, and material interfaces to help drive commercial product improvements. Drive process Improvements: Continue work on process and systems improvement as well as become the link between the Design & Development teams, Process Engineering, External Supply Chain and our Manufacturing Sites. Your will lead or support a team in manufacturing scale-ups, and site-to-site design transfers for package design and assure appropriate validation and verification steps are conducted prior to introduction and resolve any related issues at the sites. Provide solutions to a variety of highly complex technical problems of varying scope, independently evaluate, select, and/or modify standard engineering techniques, procedures and criteria. Ensuring all appropriate internal and external procedures are met.
20% Domestic and International travel
Master's degree and 3 years of Engineering experience in a GMP regulated environment
Bachelor's degree and 5 years of Engineering experience in a GMP regulated environment
Associate's degree and 10 years of Engineering experience in a GMP regulated environment
High school diploma / GED and 12 years of Engineering experience in a GMP regulated environment
Master's degree in Engineering, Science or related technological field
6+ years of package engineering or packaging equipment work experience
3+ years within pharmaceutical, biotechnology or medical device areas
Independent thinker with demonstrated skills working in teams or leading project teams. Excellent written and verbal communication skills, being able to manage relationships remotely. Strong team-oriented skills, self-driven with ability to drive projects requiring cross-functional and remote collaboration. Ability to multi-task and manage timelines. Ability to work in a highly regulated and ever-changing industry. Comprehensive understanding of materials used in packaging. Good understanding of current Good Manufacturing / Documentation Practices and familiarity with validation and verification processes and protocols. Good understanding of equipment used in the packaging industry.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions
that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since
1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has
reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
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.