Blake Bittner Email & Phone Number

I have three years of temperature mapping using a Kaye validator, protocol execution, and Re-Qualification experience for projects within FDA regulated industries. I have been a valuable asset in keeping equipment qualified and up to industry standard. I have worked with a team on many group projects, which has given me hands-on experience with a large variety of equipment. Furthermore, my experience demonstrates exceptional verbal and written communication skills and comfort functioning both independently and as a team.Years of GmP Experience: 3Years of Validation Experience: 3Areas of GmP Validation Exposure: Equipment Validation, Re-qualification, Temperature mapping (Kaye validator 2000), Clean room SUMMARIES OF EXPERTISESpecialties: assembly language, configuration management, cpr certified, documentation, file management, first aid, microsoft windows 2000, packaging, photography, protocols, safety, sat, sop, transportation, validation, vision,

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  Validation Technician

  Meridian Medical Technologies

  Jan 2007 - Present

  Set-up and programmed Kaye validator 2000 programs for various temperature and humidity mappings and protocols to be executedInvolved in the Experimental Protocols to evaluate the feasibility of supplier change on Seidenader automated inspection machineRequalification 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 equipmentHave an understanding of validation change control and its significanceExperience working with Cognex camera systemGeneral Equipment Validation SummaryClean & PrepWashing 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 trucksWarehouseOther ExperienceWriting of safety SOPDocumentation control40 hours of Opex green belt trainingSafety officer (first aid and CPR certified)Updating log booksGown Qualified for clean roomUtility Verification