Process Development Engineer

Seeking a Process Development Engineer to join the Drug Substance Technology 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 harvest and 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. Responsibilities Under guidance of senior staff, the Engineer performs the following: Transfer purification 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 Required Skills 2 YOE post graduation required At-scale biologics purification knowledge and experience Strong understanding of data analysis tools Excellent communication and troubleshooting Preferred Skills 1+ Years of Process Engineering Experience preferably related to scale-up principles and commercial cGMP manufacturing facilities Master's Degree in Chemical or Biochemical Engineering 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 Background in biologics tech transfer into commercial facilities Purification process knowledge Knowledge of purification processes/equipment; scale up factors from chromatography, UF/DF, process deviations, raw materials to growth and quality attributes 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 #J-18808-Ljbffr Crystal Equation Corporation