Auxillium: Validation for start up of the biotech’s new production train. Qualified cGMP utilities, walk in cold rooms, process vessels, process equipment cGMP washers and control systems. Duties included writing justifications and protocols for equipment and executing qualifications with follow-up reporting. |
MedImmune: Multiple projects at four individual sites (Manufacturing, Pilot Plant, Warehouse, Fill Finish Facility). Function as Automation qualification support with signature authority for BMS and PCS installations and upgrades. Qualified multiple software upgrades to Siedenader vision inspection machine. Automation qualification for new high speed filler used to support of H1N1 vaccine production. Installed, integrated, qualified and provide continuing support for automated environmental monitoring software for class 100 filling suites. cGMP equipment qualified includes cGMP Utilities including WFI, Compressed Air, Clean Steam and RODI. Process equipment including bioreactors, chromatography, transfer panels and filtration skids. Controlled temperature units qualified include incubators, refrigerators, freezers, -80C freezers and warehouses. Thermal mapping is accomplished with wireless data accumulators instead of strung thermocouples.
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Costco Wholesale: Installed and preform long term temperature and humidity wireless monitoring system. This system monitors over 50 points inside multiple temperate range rooms with alarm and notification capability. This system is fully wireless and was installed with no interruption of normal operation.
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Centocor: Qualify equipment at Building 4 manufacturing facility for start-up and later at the R&D Pilot Plant facility in support of on-going development processes. All aspects of start-up qualifications from SCADA and BMS to process equipment including bioreactors and down-stream purification and cGMP Utilities for WFI, RODI and clean steam.
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Neose: Function as the validation department for the company with signature authority. Responsibilities include maintaining qualification status for all cGMP equipment, instruments and utilities. Qualification of laboratory instruments, controlled temperature units (CTU’s) and utilities for this early development biotech company.
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TyRx: Performe “real-time” wireless thermal map of an oven used for a time and temperature critical process with no thermocouple intrusions to alter data.
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MacroGenics: Given signature authority for start-up qualification activities for this biotech company. Reviewed and approved qualifications for all portions within the cGMP envelope.
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