Blake Bittner Email & Phone Number

Raleigh, North Carolina, Us

Allosource Skin and Tissue• Multi building freezer move with 300+ units • Honeywell and Amega monitoring systems• Revised SOP’s• Clean room/sterilizer workThermoFisher• Sterilizer IQ/OQ/PQ• Steam Generator IQ/OQ/PQ• Water System validation DSM Dyneema • Edwards Audit response• Process validaitonRoche Carolina• Review validation deliverables and site procedures to determine system compliance with FDA regulations and company policies and procedures.• Develop Remediation Plans to address any gaps in system compliance with FDA regulations and company policies and procedures.

St Louis, Missouri, Us

2007 - 2010Set-up and programmed Kaye validator 2000 programs for various temperature and humidity mappings and protocols to be executed. Preformed analysis of data for final summaries and submissions. Requalification of transportation trucks to keep FDA compliantKnowledgeable in Pharmaceutical (Parts 210 & 211) FDA Code of Federal RegulationsExperience in SAT (Commissioning and Qualification), Validation, On-Going Maintenance / Change and Configuration Management.Experience in Re-Qualification of company entities Authored, Executed, Lead, Managed, and Reported on complete life cycle of system Validation deliverablesInput/output verification on new equipmentSolid understanding of change control and its significanceExperience working with Cognex camera systemDocument control for Validation DepartmentCreated storage data bases for electronic filesSet up meetings and conferences to have documents approved.Updated logbooks Writing Standard operating proceduresGeneral Equipment Validation SummaryClass 100,000 and 1,000 equipment and component preparation area qualified.Washing Studies Aseptic ProcessingHarro Hoflinger filling machineSmoke StudiesNHGD vision systemSteris SterilizerGruenburg dry heat ovenPackaging EquipmentNGA automated assembly lineEpic Automated Assembly machinePouching machineTBS SealerLabeling EquipmentAesus Labeling MachineNutropin carton sealerProcess ValidationSterilization load QualificationSterisSSMAMSCONew load qualification Huber WasherSeidenader Automated inspection machineEnvironmental ChambersInstallation and qualification of environmental chambersRe-qualification of environmental chambers Lab EquipmentOptical ComparatorVacuum ChamberMicroscope/camera experienceTemperature MappingCoolersIncubatorsIncubators with humidityEnvironmental chambersTransportation trucksWarehouse

Bachelor Of Science, Business Management

Education record

Associates, Liberal Arts