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Chemical Engineer

Company: Donatech Corporation
Location: Thousand Oaks
Posted on: March 18, 2020

Job Description:

Support a Fortune 500 Biotech-Pharma Company as a Process Development Engineer. PREFERRED QUALIFICATIONS: --- Master's Degree in Chemical or Biochemical Engineering --- 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 or knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes Job Description:Seeking a Process Development Engineer to join the Drug Substance Process Engineering team at our Thousand Oaks facilities. 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 a new innovative manufacturing suite using single use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic single-use manufacturing facility. JOB RESPONSIBILITIES: Under guidance of senior staff, the associate engineer performs the following: - Transfers cell culture drug substance processes and performs process improvements from the laboratory into the manufacturing facility - Provides technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation - Offers process validation support for late stage commercial processes - Provides routine process monitoring and troubleshooting - Executes data trending and statistical process analysis - Supports technical direction for process related deviations (NCs), CAPAs and change controls - Identifies and supports process related operational excellence opportunities - Represents process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory BASIC QUALIFICATIONS: Master's degree OR Bachelor's degree Associate's degree and 7 years of Engineering or Operations experience OR High school diploma / GED and 8 years of Engineering or Operations experience

Keywords: Donatech Corporation, Thousand Oaks , Chemical Engineer, Engineering , Thousand Oaks, California

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