Cv / Resume Gary L Burgess PE - Process Mechanical Engineer

1. GARY L. BURGESS, P.E.
8928 Castlebay Dr. Gary.L.Burgess@gmail.com
Charlotte, NC 28277 http://www.linkedin.com/in/garylburgess
704-543-1879 Skype live: gary.l.burgess
Validation / Quality Engineer with experience is all phases ofvalidation including Automation Installation
Qualifications / Operational Qualifications (AIQ /AOQ), Cause and Effect Diagram / Fishbone / Ishikawa
Diagrams, Change Control, Commissioning, Corrective Action / Preventive Action (CAPA), Design
Remediation & Validation Plans, Design Qualifications (DQ), Factory Acceptance Testing (FAT), Functional
Requirements Specifications (FRS), Installation Qualifications (IQ), Operational Qualifications (OQ),
Performance Qualifications (PQ), Regulatory & Complexity Assessment (RCA), Site Acceptance Testing (SAT),
Systems Requirement Specifications (SRS), Trace Matrixes, Turn Over Package (TOP), and User Requirement
Specifications (URS).
Process / Facilities Engineer with experience in all aspects of engineering including design, operations,pilot
plant study, process development, P&ID’s, PSM, R&D, & troubleshooting.
Project Engineer / Manager in handling complete project cycle, including sales, marketing, design,scheduling,
budgeting,commissioning, startup & validation.
Process Industries of Biotechnology, Food, Pharmaceutical and Specialty Chemical
1 PROENGINEER, Charlotte, NC 2002 - Present
Process / Project / Validation Engineer
 Impact Assessment / draft Corrective Action / Preventive Action - CAPA covering 17 utility systems,20
product lines for cosmetics, OTC drugs & Medical Devices. Swiss-American CDMO, Carrollton, TX
 Reviewed / commented on Protocols, Reports, Batch Records and Operations for Gamajet CIP / COP
operations. Formulated Solutions, Largo, FL
 Developed / wrote User Requirement Specifications for support of ASO – Antisense Oligonucleotide
Synthesis Manufacturing Process for 1) Ammonium Hydroxide Addition, 2) 3-Picoline Addition, 3)
Dichloroacetic Acid – DCA Addition, 4) Toluene Bulk System, 5) Acetonitrile Bulk System, 6) Deblock –
DCA / Toluene, 7) Sulfurization – acetonitrile / 3-Picoline Solution Preparation System, 8) Activator
Solution Prep and 9) SP- Scientific LyoStar 3 Laboratory Scale Lyophilizer as part of GE OG Synthesizer
Project. SMA – Spinal Muscular Atrophy – SMN1 gene Biogen, Durham / Apex / RTP, NC
http://www.ionispharma.com/ionis-spinraza-recognized-prestigious-prix-galien-award-best-biotechnology-
product/
 Reviewed Water Systems to produce 18O Isotope Water / Positron Emission Tomography (PET) - Nuclear
Imaging and 13C Isotope / Urea Inhalation per FDA Request. CIL Isotope Separations, Xenia, OH
 Provided guidance and justification for a pilot plant to produce almond milk and almond snacks. Blue
Diamond Growers, Sacramento, CA
 Developed twenty-four (24) Cause and Effect Diagram / Fishbone / Ishikawa Diagrams from review of 18O
Isotope plant for the following systems – USP Water, 13 Stage Multi-Effect Cascade, Single Step
Distillation, Ion Exchange, Electro Dialysis, Furnace, Cold Trap, Cryogenic Trap, Normalization Reactor,
Collection, UV / Ozone and Packaging Systems. CIL Isotope Separations,Xenia, OH
 Wrote User Requirement Specifications – URS for 6,000+ sq. ft. Quality Control / QC Production Lab with
93+ major pieces of equipment. Systems included; Building Management – BMS, Carbon Dioxide – CO2,
Communications, Compressed Air – CA, Data, DI Water / ASTM D1193-06 Reagent Grade Type II - Type
B / ASTM D5196-06 Bio-Applications, Electrical, Helium – He, Hydrogen – H2, Natural Gas – NG,
Nitrogen – N2, Potable Water – PW and Vacuum – VAC. Astra Zeneca / Medimmune, Boulder, CO
 Process Design for the filtration and sampling of (7) Cell Factory, (1) Microfiltration, (1) Ultra filtration,
(3) Fermentation, (3) Acid/Base, (5) Media Preparation / Hold, (1) Recovery Tank Systems and (9) CIP
Systems. This constituted 15%+ of a $10,000,000 (10) plant remediation project. Created / modified 117

2. P&ID’s drawings. Wrote 50-page URS for High Voltage Leak Detection System / reviewed FRS / FS
documentation. Merck, West Point, PA
 Process Design for converting existing COP – Clean-Out-of-Place Skid to Semi CIP systemfor cleaning
30-liter formulation vessels. Project included P&ID Modifications, General Piping Arrangement /
Construction Specifications and rebuilding components that have been out of service for 10 years .Biogen,
Durham / Apex, NC
 Investigation of comparison of Process Ranges versus Calibration Ranges of plant wide study with focus /
coverage of liquid nitrogen and refrigeration-based freeze dryers / lyophilizers, CIP, clean steam,
diathermic fluid, liquid nitrogen, sterile air / nitrogen, refrigeration systems.CMO / Sterile Pharmaceuticals
- Fresenius Kabi, Grand Island, NY
 Developed 1100-line MS Project Schedule for Installation / Validation of nine (9) consumer good projects.
QualPak / GoJo, Laurinburg, NC
 Project Manager for design / installation of Blend Skid for production of nonwoven wet wipes. Developed
process for zero discharge / CIP – Clean in Place Blend Skid - $300,000. US Nonwovens, Brentwood, NY
 Project / Construction Manager for cell culture media CIP systemwhich included 800 automatic sanitary
welds for Mixer, Mill, Dispenser system- $250,000. Cell Therapy / Endotoxin Detection - Lonza
Bioscience / Cambrex Bioscience, Walkersville, MD
 Developed 18 P&ID’s for the upgrade / enhancement of bleaching & refining plus designs for reducing
water & steamconsumption for (2) edible oil plants. Cargill, Charlotte, NC, Cargill, Sioux City, IA
 Identified 15 API Plant Safety Issues. Developed Scope of Work and Designs for correction. High Potency
(HPAPIs) & Cytotoxic Compounds/Controlled Substances - Irix Pharmaceuticals / Patheon, Greenville, SC
 Designed & developed bid packages for filtration, ultrafiltration, diafiltration, CIP & chromatography
skids. bioMerieux, Durham, NC, Talecris Bio therapeutics, Clayton, NC, Wyeth,Sanford, NC, Haemacure,
Sarasota, FL
 Developed design & construction documentation for single use bioreactor installation, single-use centrifuge
test room, and caustic kill / acid neutralization systemmodifications along with other utility upgrades.
CDMO – Cell Therapy KBI Biopharma, Durham, NC, KBI Biopharma, RTP, NC,
 Developed multiple infrastructure & process improvement / addition projects for adhesive, coating &
agricultural intermediates projects to add plant capacity, improve operations & reduce costs.Coatex,
Chester, SC, Chemdal, Aberdeen, MS, EON Labs / Novartis, Wilson, NC
 Developed P&ID’s for an active pharmaceutical ingredient - API - Thin Film Evaporation CIP system.
Completed estimates for Design Qualifications (DQ), IQ & OQ along with preliminary scope / system
integrator interviews for a 21 CFR Part 11 compliant Intellution batch control system. Technology
Development Corporation, Charlotte, NC
 Wrote and / or approved Change Control, Commissioning, Functional Requirements Specifications,
Remediation & Validation Plans, Trace Matrixes, Automation Installation & Operational Qualifications,
(AIQ) & (AOQ) and Performance Qualifications (PQ) for biological products infrastructure,USP Water
System & Water for Injection - Building Management Systems (BMS). Participated in AIQ / AOQ and /or
FMEA of HVAC, airlock / door, compressed gas, utilities, OTC / solid dose manufacturing, USP Water
and / or media / buffer preparation - bioreactor process systems. Quality Review / Oversight / Approval of
utility systems. Bayer, Clayton, NC, Astra Zeneca / Medimmune, Frederick, MD, Novartis / GSK - OTC,
Lincoln, NE, Pfizer, Terre Haute, IN, Protein Design Labs / PDL BioPharma, Plymouth, MN
 Wrote Regulatory & Complexity Assessment (RCA), SRS & IQ, OQ and / or PQ documentation for
Colloid Mill, CIP, SIP - Steam in Place & USP Water process systems. Wrote dispensing / vial filling IQ,
OQ & Cold Room Automation Systems Requirement Specifications (SRS) for biotech / protein
manufacturers. EMD Millipore / Merck KGaA, Kankakee, Curium / Tyco Healthcare / Mallinckrodt,
Maryland Heights, MO, Indiana Protein Technologies,Greenwood, IN
 Completed Gap Analyses for 50 plus Pharmaceutical Processes / Equipment and Utility Systems . GSK,
Aiken, SC
 Quality review / development of User Requirement Specifications (URS) for Clean Room, UPS Water,
Nitrogen, Carbon Dioxide, Emergency Power, HVAC and Compressed Air Systems. Drawing review for
the same. Immunotherapy – Cancer / HIV / immunotherapy technology.Argos Therapeutics, Durham, NC
 Site Evaluation / Process Development / Design. Greer Labs, Lenoir, NC, bioMerieux, Durham
 Site Evaluation / Review / Turn Over Package (TOP) Development for CIP, Compressed Air, Nitrogen,
HVAC, Boiler and Electrical Systems. COPD Pearl Therapeutics / Astra Zeneca, Durham, NC

3.  Design / URS review of USP Water, Tekemas Resin Formulation, Media Formulation, and CIP Systems
for Line 4 BacT/ALERT Culture Media. bioMerieux, Durham
 Performed pre start-up review of new surfactant / Polyvinylpyrrolidone (PVP/PVPi) pharmaceutical /
excipients / prill plant. BASF, Geismar, LA
 Process Safety Management – PSM for epoxy, defoamer and acrylic monomer / photomer manufacturer /
ISO 14001 re certification. IGM Resins, Charlotte, NC
 Process Engineer for design, commissioning, startup of 125 psig 300 HP Boiler -1750 psig Condensate
Polishing initial design and the FEL-3 design for a $2,000,000 per year energy recovery project. DuPont,
RTP, PCS Phosphate,Aurora, NC, International Paper, Ticonderoga, NY
PFIZER / WYETH, MARIETTA, PA – SITE CLOSED 2001 - 2002
Project Engineer / Manager
 Developed designs for $10,000,000 Vaccine Development Center renovation.Created database for utility
requirements, relocation, calibration & installation of 450 pieces of laboratory equipment.
 Managed $750,000 Clinical Live Virus Aseptic Filling / Lyophilization Project from Scope of Work &
Basis of Design through Engineering Turnover Package & Commissioning. First project to incorporate
Corporate Project Management & Commissioning SOP & HVAC Engineering Standards .
 Led Scope of Work & Design for $500,000 Biosafety Level – 2 (BL-2) Clinical Filling / Freeze Drying
enhancement project.
 Developed designs for $400,000 cGMP – smallpox vaccine warehouse lighting / security project &
$250,000 clinical packaging relocation.
 Plant representative during construction for Cold Adaptive Influenza Vaccine (CAIV) / FluMist facility.
1 PROENGINEER, CHARLOTTE, NC 2000 – 2001
Project Engineer / Manager
 Interim Plant Engineer / Manager for agricultural intermediate contract specialty chemical manufacturer.
Organized plant information, interfaced with customers, participated in HAZOP reviews & executed
multiple process & facility projects. Projects ranged from $5,000 to $400,000+. Clariant / Nipa Hardwicke,
Rock Hill, SC
 Lead Process Engineer for the design / upgrade of USP water, DI Urea, chemical & waste inactivation
systems for insulin, parathyroid & human growth hormone manufacturer. Eli Lilly, Indianapolis, IN
EMERGENT BIOSOLUTIONS / BIOPORT, LANSING, MI 1999
Mechanical Engineer - Project Engineer / Manager
 Project Manager for $2,500,000 chiller, centrifuge, CIP & neutralization systemproject for producing
Human Plasma Derivatives Fraction II - Immune Globulin & Fraction V - Albumin.
 Project Engineer for $100,000 albumin pasteurizer relocation / controls enhancement project.
Enhancements added 3 levels of protection against a $450,000 product loss.
 Improved process safety for anthrax vaccine fermentation & separation process.
1 PROENGINEER, CHARLOTTE, NC 1993 – 1998
Project Engineer / Manager
 Designed process for converting animal blood from a traditional $600 / ton to a value added $3,800 / ton
product.Conducted pilot plant studies on collection, centrifugation, filtration, evaporation,membrane
concentration & spray drying for separating cellular fraction & drying plasma fraction. Valley Protein /
Carolina By-Products, Fayetteville, NC, Carolina By-Products, Gastonia, NC, Carolina By-Products,
Greensboro, Carolina Turkey, Mt. Olive, Milliken’s Country Sausage,Asheboro, Agropur, Saint-
Alexandre-de-Kamouraska, Que., Agropur / Lactel Group, Trois-Pistoles, Que., Randolph's Packing,
Asheboro,NC, Rocco Turkey, Raeford / St. Pauls, NC, Townsends,Pittsboro, NC, Townsends,Siler City,
NC, Community Bio-Resources, Greensboro, NC

4.  Developed process design for an emulsification upgrade project to increase vaccine efficacy, enhance
production flexibility & reduce cycle times 40% eliminating a second shift. Merck / Intervet, Millsboro, DE
 Team leader for the development & implementation of ISO 14000 program for a vaccine manufacturer.
Intervet, Millsboro, DE
 Corporate project engineer for 4 specialty chemical plants in the USA & Canada. Expanded two plants &
worked to close two plants while executing 22 infrastructure upgrade projects. Projects ranged from
$5,000 to $250,000+. Dow / Reichhold, Bramalea, Ont., Dow / Reichhold, Jackson, TN, Dow / Reichhold,
Nashville, TN, Dow / Reichhold, Toronto, Ont, Dow / Reichhold, RTP
EDUCATION
____________________________________________________________________________________
AMERICAN UNIVERSITY – CAIRO, EGYPT
International Studies
MARSHALL UNIVERSITY
Chemical Engineering – Masters Level
Professional Engineer WV 007800
MICHIGAN STATE UNIVERSITY
MS Sanitary Engineering
MICHIGAN STATE UNIVERSITY
BS Mechanical Engineering
MICHIGAN STATE UNIVERSITY
Activities
 Student Advisory Member to the Chairperson of Mechanical Engineering – 2-year elected position.
 ASME Student Chairperson – Developed program to talk to H.S. Stem Classes – 2-year position.
 Received / Awarded scholarships from High School, Mechanical & Civil Engineering Departments.
 Graduate Teaching Assistant forEnvironmental, Hydraulics & Surveying Labs.
 Five Summers Engineering Employment in Civil Engineering, Quality Assurance,Testing & Development,
Plant Engineering & Construction.
SAFETY
____________________________________________________________________________________
HAZOPS – Hazard Operability Study, FMEA – Failure Mode & Effect Analysis,PHA – Process Hazards
Analysis and / or Search for Anomalies Training with Air Products, Monsanto,GAF, Rhone Poulenc, Nipa
Hardwicke, DuPont and Novartis.
PROFESSIONAL MEMBERSHIP
____________________________________________________________________________________
 AIChE – American Institute of Chemical Engineers, ANS – American Nuclear Society, IEEE, & SME –
Society of Manufacturing Engineers former AFE – American Facility Engineers / AIPE – American
Institute of Plant Engineers, ASME – American Society of Mechanical Engineers – Chair / Secretary /
Programs, IO3 – International Ozone Society, ISA – Instrument Society of America, ISPE – International
Society of Pharmaceutical Engineers, MPA – Microsoft Project Association,MPUG – Microsoft Project
Users Group Co- Chair, NCPE – North Carolina Professional Engineers, SAE – Society of Automotive
Engineers - Professional Engineer WV 007800
 IT Membership – CBIG, CITPG – Charlotte IT Professional Group, Developers Guild, IOT, Modern Devs
Charlotte and RIOT - former member Association of IT Professionals – AITP and Microsoft Project Users
Group – MPUG / Microsoft Project Association - MPA

5. MANUFACTURING PLANTS WORKED IN WITH - 1 PROENGINEER - 787
BIOTECH – PHARMACEUTICAL - 116
____________________________________________________________________________________
Abraxis, Melrose Park, IL, Astra Zeneca, Boulder, CO, BASF, Geismar, LA, Bayer, Clayton, NC, Ben Venue
Labs, Bedford, OH, Biogen - B24, Durham, NC, Biogen - B35, RTP / Morrisville, NC, bioMerieux - Hamlin
Rd, Durham, NC, bioMerieux – Rodolphe St., Durham, NC, CIL Isotope Separations – 18O Isotope,Xenia, OH,
CIL Isotope Separations – 13C Isotope,Xenia, OH, Lonza Bioscience / Cambrex Bioscience, Walkersville, MD,
Catalent, Morrisville, NC, Community Bio-Resources, Greensboro, NC, Eli Lilly, Indianapolis, IN, EMD
Millipore / Merck KGaA, Kankakee, IL, Formulated Solutions, Largo, FL, Fresenius Kabi, Grand Island, NY,
EON Labs, Wilson, NC, Stallergenes Greer (Greer Labs), Lenoir, NC, GSK, Aiken, SC, Indiana Protein
Technologies, Greenwood, IN, Irix Pharmaceuticals (Patheon), Florence / Greenville, SC, KBI Biopharma,
Durham, NC, KBI Biopharma, RTP, NC, Medimmune, Frederick, MD, Merck, West Point, PA, Novartis -
OTC, Lincoln, NE, Pearl Therapeutics, RTP, NC, Pfizer, Terre Haute, IN, Pfizer (Intervet), Millsboro, DE,
Protein Design Labs / PDL, Plymouth, MN, QualPak / GoJo, Laurinburg, NC, Steris Isomedix, Whippany,NJ,
Swiss-American CDMO, Carrollton, TX, Transdermal Specialties, Charlotte, NC, Curium / Tyco Healthcare /
Mallinckrodt, Maryland Heights, MO
Other Biotech - Pharmaceutical – Prior to 1 Proengineer
BioPort, Lansing, MI, Bausch & Lomb, Greer, SC, Becton Dickinson, Sumter, SC, Becton Dickinson, Honea
Path, SC, DHL, Union, SC, Kendall, Walpole, MA, Pharmaceutical Associates,Greenville, SC, Span America,
Greer, SC
FOOD - 150
____________________________________________________________________________________
Agropur, Saint-Alexandre-de-Kamouraska, Que., Agropur / Lactel Group, Trois-Pistoles, Que., Campbell’s
Soup / Synder’s Lance, Charlotte, NC, Cargill, Charlotte, NC, Cargill, Sioux City, IA, Cargill, Lake Odessa,MI,
Valley Protein / Carolina By-Products, Fayetteville, NC, Carolina By-Products, Gastonia, NC, Carolina By-
Products,Greensboro, NC, Frito Lay, Charlotte, NC, Carolina Turkey, Mt. Olive, Jelly Beans, Mississauga,Ont.,
Maumee Grain, Maumee, OH, Meats, Mississauga,Ont., Milliken’s Country Sausage, Asheboro,NC, MG
Newell, Greensboro, NC, Pepsi, Mississauga,Ont., Randolph's Packing, Asheboro, NC, Reddyice, Gaffney, SC,
Rocco Turkey, Raeford / St. Pauls, NC, Townsends,Pittsboro,NC, Townsends,Siler City, NC
SPECIALTY CHEMICAL - 111
____________________________________________________________________________________
Chemol, Greensboro, NC, Coatex, Chester, SC, Chemdal, Aberdeen,MS, Dow / Reichhold, RTP, NC, High
Point Chemical, High Point, NC, IGM Resins, Charlotte, NC, Inolex, Charlotte, NC Nipa Hardwicke, Elgin, SC,
Nipa Hardwicke, Rock Hill, SC, Pesco-Beam, Roanoke, VA, Quality Terminal, Chester, SC, Reichhold,
Bramalea, Ont., Dow / Reichhold, Jackson, TN, Dow / Reichhold, Nashville, TN, Dow / Reichhold, Toronto,
Ont., DuPont, RTP, Stockhausen,Greensboro, NC, SEACO, Lenoir, NC, South Eastern Petroleum, Chester, SC,
Specialty Polymers, Chester, SC, Tailored Chemical Products, Hickory, NC
MISCELLANEOUS MANUFACTURING - 410
____________________________________________________________________________________
Arizona Glass, Casa Grande, AZ, Industrial Laundry, Bramalea, Ont., International Paper, Ticonderoga, NY,
Limitorque, Greensboro, NC, MESCOM, Charlotte, NC, MG Newell, Greensboro, NC, QualPak, Laurinburg,
NC, Dow / Reichhold, RTP, US Nonwovens,Brentwood, NY
COUNTRIES & PROJECTS INVOLVED WITH
____________________________________________________________________________________
Belgium, Brazil, Canada, China, Egypt, England, Ethiopia, Germany, Italy, Japan, Mexico, Scotland, Singapore,
South Africa, & Spain

6. COUNTRIES WORKED IN
____________________________________________________________________________________
Canada –work visa, China- work visa, Egypt – work visas, Belgium, Germany, Italy, Japan, & United States – 34
States, 2 Provinces – Quebec & Ontario (List Available)
TECHNICAL / TEACHING PRESENTATIONS – ATTENDEES – 1,037 / (143,815) *
____________________________________________________________________________________
 ACS – American Chemical Society, Charlotte, NC – 31
 ACS – American Chemical Society, Charlotte, NC – 34
 AFE – Association for Facilities Engineering, King of Prussia, PA - 29
 AIChE - American Institute of Chemical Engineers, Greenville, SC – 35
5. AIChE - American Institute of Chemical Engineers, Charlotte, NC – 25 (High Purity Water)
 AIChE - American Institute of Chemical Engineers, Charlotte, NC – 12 (Part 11 Compliance)
 AIChE - American Institute of Chemical Engineers, Charlotte, NC – 21 (WastewaterTreatment)
 AIChE – American Institute of Chemical Engineers, Charlotte, NC – 9 (Motorcycle Safety and
Technology)
 AIChE – American Institute of Chemical Engineers, Charlotte, NC (34) with ACS (Motorcycle Safety and
Technology)
10. ASME - American Society of Mechanical Engineers, Charlotte, NC – 22 (High Purity Water)
 ASME - American Society of Mechanical Engineers, Charlotte, NC – 67 (Wastewater Treatment)
 CSI – Construction Specifications Institute, Charlotte, NC - 23
 High Tech & Pharmaceutical Conference, Brussels, Belgium – 55
 IMEC, Leuven, Belgium - 10
15. Johnson & Johnson,New Brunswick, NJ – 110
 Johnson & Johnson – Centocor - Malvern, PA -10
 Kemet Electronics, Greenwood, SC – 10
 Lockwood Greene, Spartanburg,SC - 40
 Lockwood Greene, Plano, TX – 10
20. Novozymes, Salem, VA - 12
 PSPE – Pennsylvania Society of Professional Engineers Philadelphia Section, Philadelphia, PA – 27
 PENC – North Carolina South Piedmont Chapter of Professional Engineers, Charlotte, NC - 26
 Texas Instruments, Richardson, TX – 25
 MS Project Training, Wachovia, Winston Salem, NC – 16 (Instructor)
25. MS Excel Training, Computer Education Services, Charlotte, NC – 10 (Instructor)
 Microsoft – CTS Service Ready (Mission Critical / Technical Support) – 300
 Charlotte Rotary Club – Trans Canada - 11
 Winget Park Elementary 3rd Grade STEM Class / Motorcycle Safety and Technology – 18
 Winget Park Elementary 5th Grade STEM Class / Motorcycle Safety and Technology – 31
30. Winget Park Elementary 3rd Grade STEM Class / Motorcycle Safety and Technology – 26
 Winget Park Elementary 4th Grade STEM Class / Motorcycle Safety and Technology – 19
 Missed Winning Field Goal at Panthers / Giants Game – 70,298*
 Kicked Winning Field Goal at Panthers / Steelers Game – 72,217*
COMMUNITY INVOLVEMENT
____________________________________________________________________________________
Habitat for Humanity – 19 Homes / 354 +/- hours / NC & SC, Special Olympics – Track & Field, Bowling,
Swimming, Parades / GA, NC, & SC, Civitan – Founderof AnnualGolf Tournament benefiting Spartanburg
New Day House / Adopt a Highway, Annual Fall / Spring Pancake Fund Raiser / GA, NC & SC, Ruritan –
maintain small historical grave site & AnnualChicken Dinner Fund Raiser, Junior Achievement – JA Advisor,
Math Counts / Science Fair Judge, American Youth Soccer Organization – AYSO referee, FounderGolfers in

7. Transition, Volunteer National Public Radio / NPR, Marshall / Volunteer at Wachovia / Wells Fargo, Chiquita
Classic, USGA Championship Girls Junior, Charlotte and Greater Greensboro / WyndhamChampionships,
Volunteer for 2008 and 2012 Presidential Campaigns, St. Matthew Spirit Club – Working with Physically /
Mentally Challenged Young Adults,Patriot Guard Riders – 60 Rides / Rides consists ofgenerally standing at the
funeral home before and after the service and then escorting to the and standing at the grave site. Depending on
location these typically require 6 to 8 hours of your time. Scholarship Judge AIChE, Civitan & ASME, Charlotte
Rotary Club Speaker, Olympic High School Engineering Board Member / Senior Project Judge / Career Day
Advisor3 / Career & College Fair, Pine Lake Preparatory Capstone STEM Judge / Capstone Project Mentor,
Winget Park Elementary STEM Presenter on Mechanical, Chemical and Environmental Engineering, Partners in
Food Solutions, Ada’s Dairy Cooperative, Addis Ababa,Ethiopia – SOP Development – Packaging, Receiving,
Passivation,Sanitization, etc. (Clare Healy / General Mills), NC Regional Science & Engineering Judge
https://www.youtube.com/watch?v=9E6PiVVcess&feature=youtu.be
PROFESSIONAL DEVELOPMENT HOURS – 45 +/- PDH - PDU / YEAR
____________________________________________________________________________________
(Since 2009) - 50 – 32 – 37 – 63 - 48.5 – 59 – 63 – 63 – 66 – 90 – 78 - 27 and counting
1978 to 2019* – 1,373 + 27 = 1,400 PDH – Professional Development Hours / Units Combined with Plant
Worked / Toured or the Equivalent of about Three (3+) Plus Additional Masters’Degrees
This diverse knowledge allows for out of the box critical thinking compared to focusing on one discipline.
AACE – American Association ofCost Engineers
ACS – American Chemical Society
AFE – Association ofFacility Engineer
AIChE – American Institute of Chemical Engineers
AITP - Association of Information Technology Professionals
ANS – American Nuclear Society
ASHRAE – American Society of Heating Refrigeration, Air - Conditioning Engineers
ASME – The American Society of Mechanical Engineers
ASNT – American Society of Nondestructive Testing
CBIG – Charlotte Business Intelligence Group
CITPG – Carolina Information Technology Professionals Group
CSI - Construction Specifications Institute
EDG - Enterprise Developers Guild
IEEE - Institute of Electrical and Electronics Engineers
ISA – The Instrument Society of America
ISPE – International Society of Pharmaceutical Engineers
ISPI – International Society for Performance Improvement
MASC – Mid Atlantic Safety Council
MPUG – Microsoft Project Users Group
NAYGN – N. America Young Generation in Nuclear
NSPE – National Society of Professional Engineers
OWASP - Open Web Application Security Project
SME – Society of Manufacturing Engineers
SWE – Society of Women Engineers
2020 – 27 PDH
Group Speaker Affiliations Topic
ACS / AIChE Jim Passmore Sealed Air Corporation. “The Chemistry and

8. Engineering of Bubble
Wrap”
AIChE Jessica Astoria Comi Polaris
Systems, Inc.
Cryogenic
Condensation and
Vapor Recovery
ANS / ASME
ANS Marilyn Kray Exelon Generation Preserving and
Growing the US
Nuclear Power Industry
ANS / E4
Carolinas
Dr. Mark Peters Idaho National
Laboratory
Next generation of
nuclear power
ASHRAE
ASME / ASNT /
SME
ASME
CBIG
Charlotte IoT Jeremy Proffitt LendingTree The ultimate RGB
LED's, NeoPixels,
WS2812s, signs and
lights guide!!!
Charlotte IoT Troy Macera
Anant Mishra
Mayuri Deshpande
Siemens Energy, Inc. FIELD TRIP: Siemens
Industrial IoT /
MindSphere
Charlotte IoT /
NC Riot
Michael Steel
Igor Ozeruga
Tarolli IP Strategies for Small
Businesses
CITPG Nate Delanoy Segra / Spirit
Communications
How to Effectively
Deploy Large Scale
Wi-Fi!
Data Connectors Jeffrey Raymond Avanan How Hackers Bypass
Office 365 Security
Data Connectors Sean McCloskey Department of
Homeland Security’s
(DHS)
Cyber and
Infrastructure Security
Agency (CISA)
Data Connectors Greg Manson Carolinas IT
A Logically
Company
The Fear Factor:
Reducing Risk in Your
Environment
Data Connectors Anthony Iacobone SOPHOS Protection from
Today’s Biggest

9. Threats
Data Connectors Mark Johnson Arcserve Real talk on
ransomware
Data Connectors Sameer Rastogi Zerto Cyber Resilience
Data Connectors Tom Utley
Richard Moulton
Arctic Wolf
Cohesity
How to Fight Modern
Advanced Threats and
Improve Your
Cybersecurity Posture
Enterprise
Developers
Guild
Adam Vaden V2 Tools GRPC & Protobuf:
Intro to next generation
inter-service
communication
protocol
Enterprise
Developers
Guild
Carl Franklin App vNext Carl Franklin's Blazor
Road Show!
IEEE
ISPE CaSA Darren Dasburg,
Steven Pincus, PhD,
Rodolphe Barrangou,
PhD,
Todd R. Klaenhammer
Bill Monteith,
Katie Stember, PhD,
Biotech Executive
FujiFilm Diosynth
Biotechnologies
Texas
North Carolina State
Cellectis
NC Biotechnology
Center
Gene Therapy:
Progress and
Challenges in the Next
Decade
ISPE CaSA Steve McDaniel,
Kendall Kessler,
Rick Moeckel,
Tim Winstead
EwingCole
Pfizer
Claycorp, Inc.
EwingCole
Pfizer Facility Benefits
from Design-Build
Delivery of a New
R&D Lab/ Pilot Plant
ISPE CaSA Chad Merewether,
Pablo Hernandez,
Jeff Willis
PCI
PEG Contracting
Humacyte
Multifaceted approach
to Commissioning,
Qualification,
Validation, Calibration
and Maintenance
Support
Bo Crouse-Feuerhelm,
Jennifer Lauria Clark,
Christine Hofnagel,
LeAnna Pearson –
Marcum
Randy Preston
JE Dunn
Commissioning
Agents,Inc.
JacobsWyper
Architects
PharmEng
Technology
PROTECS
Maximizing Owner/
Consultant Teams for
The Best Capital
Project Outcomes - A
Roundtable Discussion
of Industry Leaders

10. Mfg Day
Microsoft Event
Microsoft Tech
Talks
Darol Timberlake Microsoft Microsoft Threat
Protection Overview
Microsoft Tech
Talks
Mike Leary Microsoft Identity & access
management with
Azure Active Directory
Microsoft Tech
Talks
Cory Williams Microsoft Information protection
and governance with
Microsoft Information
Protection
Microsoft Tech
Talks
Ed Fisher Microsoft SecOps and incident
response with
Microsoft Threat
Protection
Microsoft Tech
Talks
Darol Timberlake Microsoft Securing your
endpoints with
Microsoft Defender
Advanced Threat
Protection
Microsoft Tech
Talks
Mike Bias Microsoft Securing your on-
premises environment
from hackers
Microsoft Tech
Talks
Ed Fisher Microsoft Securing your emails
from phishing and
other advanced threat
attacks
Microsoft Tech
Talks
Ed Fisher Microsoft Reduce cost and risks
of investigations and
litigation with
Advanced eDiscovery
Modern Devs
Charlotte
Jeff Duncan Lending Tree The Interview - from
the otherside of the
table
QA Testers of
Charlotte
WEBINARS

11. ISPE
TRAVEL
Africa - Egypt,
Asia – Egypt, China & Japan,
Europe – Austria, Belgium, Cyprus, Denmark, France, Germany, Italy, Monaco, Netherlands, Spain, Switzerland
& United Kingdom
North America - Canada, Mexico & United States
50 States,1 Territory – Guam, 10 Canadian Provinces, 2 Canadian Territories – Northwest Territories & Yukon
PUBLICATIONS
Twenty-five (25) +/- articles published in four (4) different magazines.
BUSINESS HIGHLIGHTS / SUMMARY
Instrumental in the Sale of Multi-Million Dollar Processes working in a business group with Dow.
Four (4) new business resulted as a result of my experience / background / technology knowledge.
1. Monsanto sold / marketed testing service as a result of the lab and information published from the high
purity water developed / managed as part of my duties as utilities engineer.
2. Monsanto sold / marketed the ozonation of high purity water as a result of designing / starting up ozonation
systems while working with Union Carbide / Dow. This replaced the 1,000+/- gallons of 35% hydrogen
peroxide required during each ‘holiday’ plant shutdowns to sanitize high purity water systems.
3. DHL producing bottled ozonated water using the excess ‘WFI – Water’ from a vapor compression
distillation unit - VDD. The VCD unit was purchased on the surplus equipment market. My review saw
that the unit was valuable but had significant excess capacity compared to the WFI water needed to produce
intravenous solution – IV bags as part of the design of this WFI system.
4. Developed the process / design / site location to produce animal plasma feed products for both poultry and
mammalian blood for CBP Resources. This process was commercially done by Smithfield for swine blood.
No known process existed for poultry / chicken & turkey blood nor was any known information readily
available as part of the public domain.
Key player in the sale of engineering services with Lockwood Greene along with being the lead income
producing Project Managerfor over a year as a result of multiple small Preliminary Engineering or
Troubleshooting projects.
Review two hundred (200) plus annual reports while typically attending six (6) plus annual meetings per year.
Harris Teeter relocated their corporate offices and SPX removed their CEO after comments made at an annual
meeting. Although change may have been in the process it was only after my comments was anything made
public.
Annual meetings have included companies such as 1) Berkshire Hathaway, 2) Bank of America, 3) Brighthouse
Financial 4) Cato, 5) Carolina Trust Bancshares / Carolina Financial 6) Duke Energy, 7) GE, 8) Harris Teeter, 9)
Nucor, 10) Sealed Air, 11) SPX, 12) SPX Corporation, 13) SPX Flow, 14) Synder’s - Lance, 15) 3D Systems,
16) Wachovia and 17) Wells Fargo.