Barry C. Garrett

864-***-****

advvej@r.postjobfree.com

Curriculum Vitae

Education:

Southern Wesleyan University

BS in Business Administration

(Graduated with Honors)

Navy Electricity & Engineering School

Basic Engineering School

Electronic Engineering School

Electronic Radar & Communication School

Nuclear Power Pre-School

University of South Carolina

Belton Honea Path High School

(Graduated with Honors)

Experience:

06/10-Present – Senior Pastor- Pelzer First Baptist Church

03/19-Present—Validation Engineer -PL Developments-Piedmont SC-Pharmaceutical Company

●Develop, 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 Support

●Provide Quality Engineering support to Huppert and CJB for bearing / automotive measurements for customers

●Provide 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 factors

●Involved with managing sorting and inspecting of automotive components. Supervise sorting manpower, if required

●Liaison 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 issues

●Part measurement of forgings, aluminum castings and bearing assemblies ongoing engineering studies9

09/83-12/09 Bausch & Lomb - Greenville SC Solutions Facility

Pharmaceutical grade eye and contact solutions

09/89-12/09 Metrology - Senior Calibration Technician

●Controlled from a hands on level engineering projects involving plant critical equipment which required calibrations and validation

●Maintained 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 facility

●Certified ISO auditor for company, maintained NIST and NVLAP vendor qualifications by audits and interfacing with their quality organizations

●Calibrated and monitored Uv lighting systems, electrical, resistive, current, mass, pressure, temperature, incubator CIP and SIP systems and HPW flowmeters

●Developed, calibrated and validated wireless data communication for SIP data

●Maintained and calibrated photometers, and flow hoods for HEPA filter certifications

●Maintained validation data systems and validation technician usage

●Validation studies as manpower requirements dictated

●Maintain Allen Bradley and Siemens PLC systems as used in sterilization processes

●CAPA maintenance, documentation and equipment non conformances

●Certified dimensional gage standard through NIST traceable micrometer measurements, and use of other appropriate instrumentation

●Maintained, 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 systems

●Calibrated and repaired critical pH, conductivity, HPLC systems, spectrophotometers and other chemistry lab equipment for process testing

●Maintained 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 scales

●Developed electronic lab through use of Integrated Quality System software and upgrade to Blue Mountain Computerized Calibration Management software

●Maintained 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 systems

●Aseptic 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 vibratory

05/88-09/89 Validation Technician

●Developed protocols and executed them to terminate as final reports for Quality to base product release criteria

●Followed company, CGMP, and FDA requirements in protocol development, execution, data interpretation and final reports

●Developed 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-certifications

●Engineering studies of process improvements and equipment replacement viability

●Maintained validated matrix for quick reference by production departments to avoid non-conformance situations

●Directed 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 determinations

●Directed monthly detail meetings for managers to maintain cohesive study and result dissemination of validation information

●Red lined drawings as required and relayed information to engineering for critical drawing change requests

●Maintained validated product loading matrix for autoclaves from developing system validations during bi-annual validations or as required for production requirement changes

●Validated autoclave systems for special engineering projects

●Validated line and filler SIP systems for new product and tank requirements

●Validated CIP systems for product pipeline and new FCP as required through testing

●Validated Aseptic fill and fill operators

●Maintained acceptable SIP/CIP test matrix for chemistry acceptance

●Developed and maintained accurate bio-burden testing of microbiology processes

●Replaced outdated data systems for validation studies with Kaye validator 2000 and Kaye Smart probes

●Heat Distribution studies, IQ,OQ and PQ of plant steam and ETO autoclave systems

●Maintained 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 protocols

●Maintained critical change for equipment program

02/88-05/88 Technical Services Technician

●Assisted with IQ,OQ and PQ studies as plant start up and executed protocols

●Worked with Calibration manager to develop calibration and validation program objectives

●Validations of plant systems and aseptic fill operation from protocols

●Developed chemistry testing for assay requirements

●Determined required filtration media for product sterility

●Assisted microbiology in testing aseptic area, D-value determinations, bio-burden testing and media readings

●Used Kaye, and Fluke data systems for study data

●Calibrated and read chemical humidity systems in ETO validations and directed data to technician in charge

●Collected and read gas concentration data for validations of ETO sterilizers

●Assisted in formulation studies and developed chemical matrix for regulatory control of assay requirements

08/85-02/88 APA Operator

●Directed the aseptic control of filling operation

●Worked in confined class 1000 room with a class 100 area

●Maintained aseptic operations of operators

08/84-08/85 APA Prep

●Ensured class 100 and 1000 aseptic rooms were available and ready to proceed with filling operations

09/83-08/84 Sterilizer Operation

●Maintained ETO and Steam sterilizers and delivered sterilized components and equipment to aseptic filling areas

11/81-02/83 Deseret Medical – Honea Path SC

Surgical Glove Manufacturer

Maintenance Utility & Compounder

●Compounded formulations per FCP, and determined chemical assays prior to solution being used

●Maintained Allen Bradley PLC control systems and oven systems in manufacturing processes

●Rebuilt ceramic forms as deemed by production requirements

12/79-12/81 U.S. Navy

01/80-12/81 Electronics Technician

●Calibrated, rebuilt, maintained and replaced radar and communication equipment as required and as directed by schedule

●Repaired and replaced waveguide systems within ships as required

●Taught Radar and Microwave communication

●Facilitated repair on certain cryptology equipment for shared services command

●Worked on various electronic equipment as needed and directed

●Maintained radar sweep consoles and fire control targeting consoles

●Special Services

●E4 Electronic Technician

●Honorable Discharge with service connected disability

04/78-12/79 Freeman Mechanical – Greenville SC

Mechanical Construction

Pipe-fitter’s Helper

●Read 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 facilities

●Used various equipment to complete job requirements, welders, torches, threading equipment, Uv and ultrasonic welders, hand tools, large and small drill motors, etc.

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