Technical Engineer
CurrentMonitor GMP equipment for multiple departments – including regular testing and maintenance tasksCreate and manage the internal/external PM/calibration program for equipment, including, but not limited to:Synthesis and ChromatographyTFF and LyophilizationBalances and PipettesTemperature ProbesRecirculating ChillersFridge/Freezer temperature mappingFridge/Freezer probe managementManage and coordinate any external PM/calibration, including, but not limited to:Contracts/QuotesCoordinating external vendors to come onsite to perform PMsCoordinating shipping of items for calibration servicesActively look for optimization opportunitiesPerform, track, and maintain vendor training recordsTroubleshoot and manage repairs to assigned equipmentGenerate and manage a spare parts inventoryCoordinate and execute where applicable, all IQ/OQ/PQ activities, including drafting of Equipment QualificationReports (EQRs)Interface with Blue Mountain RAM to track equipment statusesCreate and execute change controls for equipmentLeading the Manufacturing move including:Relocating equipment in accordance with change controlPurchasing new equipmentAttending FATs & SATsDealing with contracts for new/existing equipmentScheduling IQOQsISO 7 and ISO 8 room qualifications at new facilityQualifying water distribution skidPMCS systemWriting new SOP/WI for equipment