About The Position

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s 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 purification 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.

Requirements

  • Biotech background
  • Downstream purification experience
  • Excellent communication skills
  • Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Responsibilities

  • Process monitoring
  • Process modeling
  • Data mining
  • Data verification
  • Deviation investigation support
  • Manufacturing support
  • Protocol drafting
  • Report drafting
  • Document review
  • Data analysis
  • Product impact assessments
  • Power point presentations
  • Validation support
  • On-site minimum 3-4 days
  • After hours on-call support including weekend
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