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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLEEMAIL AVAILABLECurriculum VitaeEducation:Southern Wesleyan UniversityBS in Business Administration(Graduated with Honors)Navy Electricity & Engineering SchoolBasic Engineering SchoolElectronic Engineering SchoolElectronic Radar & Communication SchoolNuclear Power Pre-SchoolUniversity of South CarolinaBelton Honea Path High School(Graduated with Honors)Experience:06/10-Present Senior Pastor- Pelzer First Baptist Church03/19-PresentValidation Engineer -PL Developments-Piedmont SC-Pharmaceutical CompanyDevelop, design, draft and execute Protocols and Final Reports.Train other Engineers and Validation / Calibration Techs to perform at high levels.Maintain Calibration Records and due dates.04/12- 04/19- Huppert Engineering - Engineering /Quality Liaison-Plant SupportProvide Quality Engineering support to Huppert and CJB for bearing / automotive measurements for customersProvide quality assurance for a variety of automotive components. Automotive components range from aluminum cast products, forged products and bearing assemblies.Review JIT schedules, in-plant inventories and analyses production forecasts and inventory safety factorsInvolved with managing sorting and inspecting of automotive components. Supervise sorting manpower, if requiredLiaison with all levels of plant personnel (plant management, quality assurance, engineering, process engineering, materials management and logistics)Ability to troubleshoot product quality issues, and work with the supplier and plant management in a proactive method.Resolution of quality issuesPart measurement of forgings, aluminum castings and bearing assemblies ongoing engineering studies909/83-12/09 Bausch & Lomb - Greenville SC Solutions FacilityPharmaceutical grade eye and contact solutions09/89-12/09 Metrology - Senior Calibration TechnicianControlled from a hands on level engineering projects involving plant critical equipment which required calibrations and validationMaintained and Directed other Technicians in performing Calibration program per company, FDA and NIST directives while developing SOP(standard operating procedures) equipment policies and critical controls throughout facilityCertified ISO auditor for company, maintained NIST and NVLAP vendor qualifications by audits and interfacing with their quality organizationsCalibrated and monitored Uv lighting systems, electrical, resistive, current, mass, pressure, temperature, incubator CIP and SIP systems and HPW flowmetersDeveloped, calibrated and validated wireless data communication for SIP dataMaintained and calibrated photometers, and flow hoods for HEPA filter certificationsMaintained validation data systems and validation technician usageValidation studies as manpower requirements dictatedMaintain Allen Bradley and Siemens PLC systems as used in sterilization processesCAPA maintenance, documentation and equipment non conformancesCertified dimensional gage standard through NIST traceable micrometer measurements, and use of other appropriate instrumentationMaintained, calibrated and repaired sterilization systems used in plant( ETO, Hydrogen Peroxide, steam, ultra- violet, gamma)Maintain, repair and calibrate process utility systems: water stills, steam generators, uv water sterilization, instrument air systems, HVAC chiller systems, process tank steam and chiller systems, IP controls, electronic valves, total organic carbon systemsCalibrated and repaired critical pH, conductivity, HPLC systems, spectrophotometers and other chemistry lab equipment for process testingMaintained calibration and operations of microbiological systems for testing, particle counters for viable and nonviable particulate counts, air samplers for viable particulates, isolator technologies for sterile testing, flow hoods and colony counters, bio-lab identification equipment and software, and other assorted lab equipment as analytical mass comparators and scalesDeveloped electronic lab through use of Integrated Quality System software and upgrade to Blue Mountain Computerized Calibration Management softwareMaintained lab standards accuracies as required, certification and traceable to NIST requirements (TFL 4:1 in most cases, prohibited by cost/benefit ratios)Assisted in radar, wireless pressure and wireless process tank data control additions, calibrated and directed validation of systemsAseptic fill equipment maintenance, dip fill, rotary fill, form/fill/seal and the various equipment related to operations including level indicators, mini flow meters, unscramble technologies as well as vibratory05/88-09/89 Validation TechnicianDeveloped protocols and executed them to terminate as final reports for Quality to base product release criteriaFollowed company, CGMP, and FDA requirements in protocol development, execution, data interpretation and final reportsDeveloped and executed, IQ,PQ and OQ of critical equipment systems, steam sterilizers, process vessels (100L to 40000L), water stills, chiller systems, HVAC systems, ETO sterilizers, Gamma Irradiator(cobalt) and dosing determination, VHP sterilizers, Uv systems, CIP and SIP systems, lab systems(microbiology and chemistry), fill lines and packaging lines, incubators, and controlled refrigeration systems, calibration software, Aseptic Room certifications and re-certificationsEngineering studies of process improvements and equipment replacement viabilityMaintained validated matrix for quick reference by production departments to avoid non-conformance situationsDirected and performed validation studies on plant systems as required by FDA mandates, Aseptic Fill, Tank Validations for process and distribution studies, sterilization validations of ETO, steam sterilization, gamma sterilization and hydrogen peroxide vapor including chamber distribution studies, bio burden and D-value determinationsDirected monthly detail meetings for managers to maintain cohesive study and result dissemination of validation informationRed lined drawings as required and relayed information to engineering for critical drawing change requestsMaintained validated product loading matrix for autoclaves from developing system validations during bi-annual validations or as required for production requirement changesValidated autoclave systems for special engineering projectsValidated line and filler SIP systems for new product and tank requirementsValidated CIP systems for product pipeline and new FCP as required through testingValidated Aseptic fill and fill operatorsMaintained acceptable SIP/CIP test matrix for chemistry acceptanceDeveloped and maintained accurate bio-burden testing of microbiology processesReplaced outdated data systems for validation studies with Kaye validator 2000 and Kaye Smart probesHeat Distribution studies, IQ,OQ and PQ of plant steam and ETO autoclave systemsMaintained calibration of Kaye, Fluke and other data acquisition (wireless and PLC based) systems for all validations and utilized same equipment to generate data for validation study parameters as required in study protocolsMaintained critical change for equipment program02/88-05/88 Technical Services TechnicianAssisted with IQ,OQ and PQ studies as plant start up and executed protocolsWorked with Calibration manager to develop calibration and validation program objectivesValidations of plant systems and aseptic fill operation from protocolsDeveloped chemistry testing for assay requirementsDetermined required filtration media for product sterilityAssisted microbiology in testing aseptic area, D-value determinations, bio-burden testing and media readingsUsed Kaye, and Fluke data systems for study dataCalibrated and read chemical humidity systems in ETO validations and directed data to technician in chargeCollected and read gas concentration data for validations of ETO sterilizersAssisted in formulation studies and developed chemical matrix for regulatory control of assay requirements08/85-02/88 APA OperatorDirected the aseptic control of filling operationWorked in confined class 1000 room with a class 100 areaMaintained aseptic operations of operators08/84-08/85 APA PrepEnsured class 100 and 1000 aseptic rooms were available and ready to proceed with filling operations09/83-08/84 Sterilizer OperationMaintained ETO and Steam sterilizers and delivered sterilized components and equipment to aseptic filling areas11/81-02/83 Deseret Medical Honea Path SCSurgical Glove ManufacturerMaintenance Utility & CompounderCompounded formulations per FCP, and determined chemical assays prior to solution being usedMaintained Allen Bradley PLC control systems and oven systems in manufacturing processesRebuilt ceramic forms as deemed by production requirements12/79-12/81 U.S. Navy01/80-12/81 Electronics TechnicianCalibrated, rebuilt, maintained and replaced radar and communication equipment as required and as directed by scheduleRepaired and replaced waveguide systems within ships as requiredTaught Radar and Microwave communicationFacilitated repair on certain cryptology equipment for shared services commandWorked on various electronic equipment as needed and directedMaintained radar sweep consoles and fire control targeting consolesSpecial ServicesE4 Electronic TechnicianHonorable Discharge with service connected disability04/78-12/79 Freeman Mechanical Greenville SCMechanical ConstructionPipe-fitters HelperRead and followed blueprints to install copper, galvanized, steel, acid glass and other piping as required in hospital lab setting, emergency room, surgical suite and urgent care facilitiesUsed various equipment to complete job requirements, welders, torches, threading equipment, Uv and ultrasonic welders, hand tools, large and small drill motors, etc. |
