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GARY L. BURGESS, P.E.
8928
Castlebay Dr.
(704)
543-1879
Charlotte,
NC 28277
MProengineer@aol.com
OBJECTIVE
Process/Project Engineer – Manager for
Biotech/Pharmaceutical or Related Process Industry
SUMMARY
 | Project Engineer/Manager in handling complete project cycle, including
feasibility, sales, marketing, detailed design, planning, scheduling,
budgeting, capital approval, specification, vendor selection, bid
evaluation, construction management, plant startup, acceptance &
final/engineering turnover.
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| Process/Facilities Engineer with experience in all aspects of process
& utility engineering/ design, including conceptual design, R&D,
pilot plant study, generation of PFD/PID’s, technical support, trouble
shooting, startup, commissioning & operations.
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EXPERIENCE
1 PROENGINEER, Charlotte, NC
1993 - Present
Project Engineer/Manager
| Wrote Functional Requirements Specifications – FRS, Remediation &
Validation Plans – R&VP, Validation Trace Matrixes, Automation
Installation Qualifications - AIQ & Automation Operational
Qualifications - AOQ for Biological Products Infrastructure & Water for
Injection Building Management Systems – BMS. Participated in the Operation
Qualification of HVAC & Airlock/Door Systems.
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| Developed preliminary P&ID’s for contract manufacture of an active
pharmaceutical ingredient - API using Thin Film Evaporation/distillation
along with a 12 circuit Clean-in-Place - CIP system. Completed outlines
& estimates for DQ, IQ & OQ along with preliminary scope/system
integrator interviews for a 21 CFR Part 11 compliant Intellution - iFIXTM,
iHistorianTM, & iBatchTM batch process control
system.
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| Designed process & plant design for converting animal blood from a
$600 to $3800/ton product. Conducted pilot studies on centrifugation,
conditioning, filtration, evaporation, membrane concentration & spray
drying for separating plasma & cellular fractions.
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| Multiple infrastructure & process improvement/addition projects for
adhesive, coating, agricultural intermediates & other specialty chemical
projects.
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| Lead Process Engineer for the design/upgrade of USP water, DI Urea,
chemical & waste inactivation systems for insulin, parathyroid &
human growth hormone manufacturer.
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| Managed the design, purchase & construction contracts of a tissue cell
production renovation/upgrade project.
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| Team leader for the development & implementation of ISO 14000 program
for an animal vaccine manufacturer.
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| Developed process design for an emulsification upgrade project to increase
vaccine efficacy, enhance production flexibility & reduce cycle time
40%.
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| BioPort, Lansing, MI - 1999 direct employee
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 | Project Manager for $1.5 million chiller, centrifuge, CIP &
neutralization system project for producing Human Plasma Derivatives
Fraction II - Immune Globulin & Fraction V - Albumin.
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| Project Manager for $0.1 million albumin pasteurizer controls enhancement
project. Assisted in change control, commissioning, & validation - IQ,
OQ & PQ.
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| Improved process safety for anthrax vaccine fermentation & separation
process.
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| Wyeth, Marietta, PA - 2001/2002 direct employee
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| Managed $0.75 million Clinical Live Virus Aseptic Filling/Lyophilization
Project from Scope of Work - SOW & Basis of Design - BOD through
Engineering Turnover Package - ETOP & Commissioning. First project to
incorporate Project Management & Commissioning Standard Operating
Procedures – SOP’s & HVAC Engineering Standards.
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| Developed designs for $10 million Vaccine Development Center renovation.
Created database for utility requirements, relocation, storage, calibration
& reinstallation of 450 pieces of laboratory equipment.
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| Led Scope of Work & Design for $0.5 million Biosafety Level – 2
(BL-2), non Live Virus Clinical Filling/Freeze Drying – Packaging
enhancement project. Project included new 300 square feet Laminar Flow Unit
- LFU with near continuous low wall returns.
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| Developed SOW & designs for $0.4 million cGMP – small pox vaccine
warehouse lighting/security project & $0.25 million clinical packaging
relocation.
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| Plant representative during construction of 25,000 sq ft Cold Adaptive
Influenza Vaccine facility & 5,000 sq ft expansion design for doubling
the dosages of the initial facility.
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MARATHON, Augusta, GA 1991 - 1992
Process/Project Engineer - Manager
| Managed design, construction, & startup of a $3 million polymerization
process addition increasing capacity 350%.
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| Completed all remaining project management & engineering commitments
as the last working employee during the closure of Marathon's Southern
Engineering Office.
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RHODIA/Rhone Poulenc, Spartanburg, SC 1989 – 1991
Plant Engineer - Manager
| Managed all project/engineering, environmental, maintenance, & utility
functions. Managed the design, construction, HAZOP & startup of a $1
million ethylene oxide derivatives batch reactor project improving cycle
times 35%. Assisted in the design, permitting & construction of a $2.5
million wastewater treatment plant & a $9 million phosphate ester batch
reactor process, warehouse, tank farm, cGMP drumming & DCS project.
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LOCKWOOD GREENE/J. A. Jones, Spartanburg, SC 1983 – 1989
Process/Mechanical Project Engineer – Manager
| Leading High Tech/Pharmaceutical income producing project manager for over
a year. Projects focused on the design, troubleshooting, & startup of
process/utility systems.
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ONSANTO/MEMC, Spartanburg, SC 1980 - 1982
Facilities Engineer
| Managed utility systems & maintenance/operation technicians.
Coordinated acceptance, startup, tie-in & operation of utilities with
each new manufacturing department during phased 14-month construction &
startup of brown field microelectronics silicon wafer plant.
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DOW CHEMICAL/Union Carbide, Technical Center, S. Charleston,
WV 1975 - 1980
Process/Project Engineer
| Business team member for the design, development, marketing, & sales
of pure oxygen biological reactor & disinfection/chemical enhancement
ozonation systems.
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EDUCATION
WEST VIRGINIA COLLEGE OF GRADUATE
STUDIES - Chemical Engineering
MICHIGAN STATE UNIVERSITY
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MS Sanitary Engineering – 1975 BS Mechanical
Engineering – 1973
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