Kevin Richard Laufenberg
Olive Branch,MS
Summary
Results oriented professional with demonstrated experience and accomplishments in the biomedical, biotech, pharmaceutical and laboratory industries. Experienced in laboratory analysis and procedures, radiation safety and safety systems, calibrations and calibration management, validation, facilities management, facilities and laboratory/medical equipment management, maintenance and repair, security systems administration, project tracking, contractor and service technician management, inventory control, and staff supervision. Honest and reliable self-starter who is a dedicated team player committed to ensuring customer service in a timely, efficient and cost effective manner.
Overview
39
39
years of professional experience
Work History
Radiation Safety Officer
Charles River Laboratories International Inc
Memphis, TN
06.2015 - Current
- Radioactive Material License site contact for the State of Tennessee Division of Radiological Health Regulations
- Schedules and maintains records of preventative maintenance for the gamma cell and x-ray irradiators and calibration of survey meters
- Management of logging in and disposal records for radioactive materials and sources for the site
- Responds to radioactive materials spills, monitors for contamination, cleans up or supervises the cleanup and disposal of materials
- Performs radioactive surveys and wipe tests, analyzing results using scintillation counters and survey equipment
- Administrator and Manager of Landauer Dosimetry Badges and Rings, and dosimetry reports for the site
- Provides formal annual and informal radioactive materials training for all site personnel
- Investigated incidents involving potential overexposure or contamination to identify root causes and recommend solutions.
Facilities Systems Administrator/Supervisor
Charles River laboratories
Memphis, TN
06.2015 - Current
- Metasys Building Monitoring System Administrator
- Building Access Administrator
- Calibration, preventative maintenance, use and repair of all laboratory, biomedical, and facilities equipment
- Use of Blue Mountain Regulatory Asset Manager
Facilities Calibration and Compliance Specialist
PharMEDium Services LLC
Memphis, TN
04.2010 - 06.2015
- Managed the calibration and preventative maintenance program (Faciliworks CMMS) for all PharMEDium sites
- Supervised clean room certification
- Performed equipment validations
- Administrator of the Honeywell Monitoring System
- Developed process and improvement of shipping, packaging, compounding procedures
- Conducted all inspection activities at multiple sites to determine compliance with SOPs
- Developed and revised standard operating procedures
QC Chemist
PharMEDium Services LLC
Memphis, TN
04.2010 - 11.2010
- Received, stored and logged-in sample testing analysis
- Established and performed sample analysis per cGMP/GLP guidelines
- Troubleshot all instrumentation
- Generated quality data trend reports
- Executed company's protocols, keeping safety the top priority
Biomedical Engineer
Methodist Hospitals
Memphis, TN
08.2009 - 03.2010
- Planned and conducted preventative maintenance and repair of medical equipment, such as: warmers, infusion pumps, centrifuges, EKG’s, vital signs monitors, defibrillators, and other biomedical equipment
Facilities and Calibration Management/Master Mechanic
Cell Genesys, Inc.
Memphis, TN
01.2003 - 01.2009
- Calibrated, performed preventative maintenance, used and repaired of all laboratory and facilities equipment
- Responsible for validation of laboratory and facilities equipment
- Performed basic checks, repairs, and maintenance of building utility systems, such as HVAC, emergency generators, electrical backup systems, and plumbing
- Utilized the Blue Mountain Calibration Database (Version 4) for maintaining calibration records, and the AMMS (Advanced Maintenance Management System) for maintaining repairs and preventative maintenance records
- Experienced in clean room requirements and differential pressure calibrations
- Scheduled and oversaw the maintenance and recertification of fume hoods and biosafety cabinets
- Environmental Health and Safety
- Fire and sprinkler systems
- IT and phone systems administration, maintenance, and repair
- Radiation Safety Officer
- Created and maintained equipment and facility files
- Administration of building security system
- Managed the ordering and monitoring of specialty gases(Carbon Dioxide and Liquid Nitrogen)
- Administrator of the Siemens Building Monitoring System (Insight version 3.4 and 3.8.1)
- Ordered and maintained equipment spare parts inventory
- Developed and generated SOPs
- Collaborated with contractors and service technicians to maintain and ensure proper cGMP documentation
- Reviewed and maintained documentation and records according to cGMP, and FDA, guidelines
- Managed and oversaw the startup of Laboratory operations with new facilities
- Member of the Cell Genesys Safety Committee
- Responsible for setting up maintenance and service contracts
Calibration/Metrology Technician
Covance Laboratories
Madison, WI
01.1996 - 01.2003
- Responsible for preventative maintenance, calibration, repair, installation, configuration, and running the Operational Qualification Performance Verification for Agilent/HP 1100 and 1050 HPLC systems, using Chemstation and Chemstore
- Validated and performed temperature mapping of environmental stability chambers
- Calibrated, repaired, performed preventative maintenance and verification of laboratory instrumentation and a variety of laboratory/medical equipment such as thermometers, infusion pumps, centrifuges, EKG’s, pipettes, laboratory balances, scales, weights, and sphygmomanometers (devices for measuring blood pressure)
- Managed inventory of instrument parts
- Used Blue Mountain Calibration Database for maintaining calibration records
- Diagnosed and repaired malfunctions using a variety of test equipment such as multimeters, oscilloscopes, gauges and hand tools
- Fabricated and repaired cables for interfacing components of GC and HPLC chromatography systems
- Assisted in the installation and maintenance of the Digital Clock System
- Managed and performed maintenance and repair of the Rees Temperature Monitoring System
- Responsible for the calibration of Rees and Metasys systems
- Reviewed and maintained documentation and records according to GLP, cGMP, FDA, EPA and ISO 9001 guidelines
Research Assistant/Chemist; Environmental Fate, Ag. Chemistry, Animal/Plant Metabolism
COVANCE LABORATORIES, a LabCorp Company
Madison, WI
01.1989 - 01.1996
- Participated in the characterization of pesticide residues in plants and animals
- Performed extraction of animal, plant, and soil matrices, and chromatographic analyses of extracts
- Analyzed samples by HPLC, GC/MS, TLC and radiotracer techniques
Laboratory Technician / Team Leader, Metabolism/Radiochemistry
COVANCE LABORATORIES
Madison, WI
01.1986 - 01.1989
- Responsible for Microbiology- media preparation, streaking samples on plates, colony counting
- Conducted maintenance and repair of sample oxidizers and liquid scintillation counters, calculating and proofreading data, and monitoring data
- Performed sample preparation and radio analysis
- Supervised laboratory personnel and monitored projects
Education
Electronics Servicing Program Diploma -
Madison Area Technical College
Madison, Wisconsin01.1993
Bachelor's Degree - Biology
University of Wisconsin-Platteville
Platteville, WI01.1984
Skills
- Proficient in MS Office, Windows NT, Blue Mountain Calibration Database, Instrumental software such as Agilent's Chemstation and Chemstore
- Advanced in Johnson Controls Metasys
Technical Training
- CyberMetrics FaciliWorks Training, Chicago, IL, 06/01/11
- Agilent 1100 HPLC System Hardware Maintenance, Repair and Troubleshooting training, Little Falls, DE, 05/01/01
- HP/Agilent 1100 Troubleshooting and Maintenance, Madison, WI, 01/01/98
- Hacker Robot Cover slipping Machine Maintenance and Repair, Fairfield, NJ, 01/01/98
- HP5890 Troubleshooting and Maintenance, Brookfield, WI, 01/01/97
- Beckman High-Performance Liquid Chromatography (HPLC) System Gold Training, Madison, WI, 01/01/96
- HP1050 HPLC Maintenance Training, Madison, WI, 01/01/92
Professional Development
- Radiation Safety Officer Training, 05/01/07, Engelhardt & Associates, Inc., Madison, WI
- NCSL International Madison Wisconsin Section Training, 01/01/01, Madison, WI
- Current Good Manufacturing Practice (cGMP) Training and refresher courses, Covance Laboratory Inc., Annually
- Good Laboratory Practices (GLP) Training and refresher courses, Covance Laboratory Inc., Annually
- Radiation Safety Training, Covance Laboratory Inc., Annually
- Lab Standard Refresher Training, Covance Laboratory Inc., Annually
- Fundamentals of Measurement Techniques, A-Z Metrology, Madison, WI, 01/01/98
- Six Sigma Training and refresher courses, Covance Laboratory Inc., Annually
References
References available upon request.
Timeline
Radiation Safety Officer
Charles River Laboratories International Inc
06.2015 - Current
Facilities Systems Administrator/Supervisor
Charles River laboratories
06.2015 - Current
Facilities Calibration and Compliance Specialist
PharMEDium Services LLC
04.2010 - 06.2015
QC Chemist
PharMEDium Services LLC
04.2010 - 11.2010
Biomedical Engineer
Methodist Hospitals
08.2009 - 03.2010
Facilities and Calibration Management/Master Mechanic
Cell Genesys, Inc.
01.2003 - 01.2009
Calibration/Metrology Technician
Covance Laboratories
01.1996 - 01.2003
Research Assistant/Chemist; Environmental Fate, Ag. Chemistry, Animal/Plant Metabolism
COVANCE LABORATORIES, a LabCorp Company
01.1989 - 01.1996
Laboratory Technician / Team Leader, Metabolism/Radiochemistry
COVANCE LABORATORIES
01.1986 - 01.1989
Electronics Servicing Program Diploma -
Madison Area Technical College
Bachelor's Degree - Biology
University of Wisconsin-Platteville
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