Job Description

Job Summary:

Engineer I will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes:

  •  Leading technical transfer projects for platform and/or repeat early-mid stage clinical manufacturing programs
  • Supporting business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client
  • Performing facility fit activities including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, and generation bill of materials (BOM) and new pacifications
  • Providing technical support for cGMP production runs, deviations, change controls, and CAPAs
  • Compiling process data and communicating out to the client and upper management via production updates and campaign summary reports. 
  • Suppor...
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