Amgen Principal Engineer in Thousand Oaks, California
As part of the Drug Substance Technology and Engineering group within the Process Development organization, one of the primary responsibilities for the principal engineer position will be to provide leadership for introduction of new technologies into the global manufacturing network, using his/her process engineering and equipment design experience to assess risk and benefits of technologies and to ensure their robust performance.
This position can be located at either our Thousand Oaks, CA site or our Cambridge, MA site.
Lead and solve complex problems in a matrixed environment.
Analyze available data, research technical subjects, and work with other subject matter experts to support rigorous technology evaluations.
Support the Amgen global network as a drug substance subject matter expert.
Provide leadership on various workstreams related to troubleshooting existing technologies and improving technology robustness.
Support technical visits to evaluate external technology capabilities and to assess new technologies that could provide cost, throughput, or other benefits to Amgen manufacturing.
Doctorate degree and 2 years of Engineering or Operations experience
Master’s degree and 6 years of Engineering or Operations experience
Bachelor’s degree and 8 years of Engineering or Operations experience
Associate’s degree and 10 years of Engineering or Operations experience
High school diploma / GED and 12 years of Engineering or Operations experience
Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment
8+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
Experience working with commercial manufacture of biologics using single use technology
Strong understanding cGMP requirements
Experience with regulatory filings and inspections
Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
Deep understanding of operational aspects of biopharma and/or engineering industries
Ability to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
Ability to prioritize efforts and delegates resources.
Experience in the analysis of data generated from a variety of analytical techniques
Strong oral and verbal communication and presentation skills enabling strong relationships with internal and external stakeholders
Ability to derive insightful strategies to improve business processes