Process Development Engineer #JN -062021-64890

Thousand Oaks, California
Industry: Database Administrator / Engineers
Job Number: JN -062021-64890

 Description:

  • Seeking a Process Development Engineer to join the Drug Substance Process Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
  • The Engineer will apply cell culture process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.

 Job Responsibilities:

  • Under guidance of senior staff, the Engineer performs the following:
  • Transfer cell culture Drug substance processes and performs process improvements from the laboratory into the manufacturing facility
  • Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
  • Offer process validation support for late stage commercial processes
  • Provide routine process monitoring and troubleshooting
  • Execute data trending and statistical process analysis
  • Support technical direction for process related deviations, CAPAs and change controls
  • Identify and support process related operational excellence opportunities
  • Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

 Basic Qualifications:

  • Master’s degree OR Bachelor’s degree and 2 years of Engineering or Operations experience
  • Associate’s degree and 6 years of Engineering or Operations experience OR High school diploma / GED and 8 years of Engineering or Operations experience
  • Master’s Degree in Chemical or Biochemical Engineering (ideal not mandatory)
  • 1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
  • Background in biologics tech transfer into commercial facilities

Upstream process knowledge:

  • Knowledge ofcell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, and process deviations, Strong capability of analysis, troubleshooting and problem solving
  • Ability to develop and follow detailed protocols
  • Independently motivated with ability to multi-task and work in teams
  • Excellent written and verbal communication skills with technical writing and presentation experience

 

 


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