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 programsSupporting business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the clientPerforming facility fit activities including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, and generation bill of materials (BOM) and new pacificationsProviding technical support for cGMP production runs, deviations, change controls, and CAPAsCompiling process data and communicating out to the client and upper management via production updates and campaign summary reports. Suppor...
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