Day to Day:
Our client is looking for multiple Downstream CQV Engineers to join their team in Raleigh-Durham. These engineers will support drug substance manufacturing buildings and help support process equipment. Process Equipment includes, but not limited to Buffer/Media Preparation, Buffer Hold, Chromatography Skids, Chromatography Columns, Column Packing, Product Hold Arrays, Ultrafiltration/Diafiltration, Intermediate Bulk Fill, Filtration Skids, Transfer Stations, Harvest/Centrifugation, Seed and Production Bioreactors.
The engineer will collaborate with cross-functional teams to support the successful delivery of the equipment scope project, ensuring that all operational systems are safe, reliable, and meet the intended design specifications. Support generation and execution of CQV lifecycle documentation including Factory Acceptance Testing (FAT), wraparounds, Design Qualification (DQ), Requirements Trace Matrix (RTM), Quality Risk Assessment (QRA), Site Acceptance Testing (SAT), Installation Qualification, Operational Qualification, Performance Qualification, including Final Reports.
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