GREGORY HARRELL2813 INGRAM DRIVE

GRAND PRAIRIE TX, 75052817-832-3309

harrellg@prodigy.nethttps://www.linkedin.com/in/gregory-harrell-b2731314

SummarySenior Engineer with 20 years of experience in Process, Metrology, Facilities, and Maintenance Management. Extensive validation experience in pharmaceutical equipment and systems for GxP compliance (i.e., FS209E, ISO 14644). Strong background in critical systems such as: WFI, Clean Steam, Compressed Air, and HVAC. Seasoned in corrective and preventative maintenance practices, process and systems for operational support and compliance. Familiar with the following applications: AutoCAD, Blue Mountain Preventative Maintenance software (CMMS), and Engineering drawings (i.e., Blueprints, CAD, P&IDs).

EXPERIENCE HIGHLIGHTS

PSC BiotechSenior Validation Engineer2015 – Present

Contract engineering position to develop and prepare SOP (Standard Operating Procedures) to comply with ISO13485.

Validation in pharmaceutical equipment and systems

Alcon LaboratoriesProcess Engineer/Technical Leader2011 – 2015

Supervised a Process Development team to study the material compatibility of pharmaceutical consumer products to assist manufacturing production with new drug manufacturing equipment process.

Alcon LaboratoriesFort Worth, TexasEngineering/Maintenance Manager2009 – 2011

Managed the Process Development Engineering/Maintenance department. Responsible for direct report year end reviews. Assisted with the scheduled maintenance and demand maintenance for all building systems and equipment. Saved over $500,000 capital budget.

Project management: Coordinated, supervised, and completed semi-annual shutdown activities. Heat Exchanger Design and Installation, and commissioning. Aseptic filling machine design, installation and validation.

Engineering/Maintenance/Validation. Coordinated demand maintenance of non-critical systems

through CEP (central Energy Plant)and PEMO (Plant Engineering Maintenance and Operation)

Alcon LaboratoriesFort Worth, TexasProject Principal Engineer I2001 – 2009

Pharmaceutical aseptic process design and operation. Facility planning and design. Research and pharmaceutical equipment and critical system

engineering -WFI, Clean Steam, Compressed Air, HVAC. Reactor and mixing engineering, procurement, validation

(IOPQ), operation and maintenance. Designed and maintained reactor Mechanical Seals. Basic Electrical Troubleshooting of process systems, critical and

non-critical utilities. Heat Exchanger- Design, installation and maintenance Aseptic Filling Machine-developed User Requirement

Specification (URS), Design review, FAT, Validation (Installation and operation), maintenance,

Controlled area- engineering, construction and operation for air flow, materials of construction and environmental monitoring of temperature, smoke testing, HEPA filter testing, relative humidity, differential pressure and NVP (non-viable particulates).

GREGORY HARRELL2813 INGRAM DRIVE

GRAND PRAIRIE TX, 75052817-832-3309

harrellg@prodigy.nethttps://www.linkedin.com/in/gregory-harrell-b2731314

Sterilization processes and equipment engineering. Automation of equipment, systems and processes including

SCADA (Supervisory Data Acquisition and Control), and Metasys (Building Automation System).

Validation of pharmaceutical equipment and system for GxP compliance.

Metrology practice, process and systems. Corrective and preventive maintenance practice, process and

systems for operational support and compliance. Capital and expense budget strategic planning, preparation and

performance tracking. Evaluate and implement corrective and preventive maintenance

events. Process Engineering Automated systems for data monitoring, process control and

modeling/simulation. Primary contact for after-hour maintenance alarms related to

facilities, environmental, critical systems, equipment, and troubleshooting, validation

Alcon LaboratoriesSenior Engineers1997-2001

Engineering/Maintenance/Validation Assist with maintenance of facility and critical equipment,

calibration, and capital budget Primary contact for after-hour maintenance alarms related to

facilities, environmental, critical systems, equipment, and troubleshooting, validation.

Commissioning and Validation of a multimillion dollar upgrade of the existing GMP Clinical. Responsible for verifying the installation during construction and testing after completion of construction.

Intern facility engineer manager responsible for capital budget, day-to-day plant operations, and facility upgrade.

Reviewed critical systems P&IDs (AutoCAD) for accuracy.

Alcon Laboratories1994 -1997

Process Development Engineer-developing, purchasing, and implementing of processing equipment

Alcon LaboratoriesValidation Contractor Engineer1993 -1994

Validation of a new GMP Clinical facility (IOPQ of critical utilities and facility)

Reviewed P&IDs to verify accuracy of deliverables.

Arlington ISDArlington Texas1991-1994

General DynamicsFort Worth, TX1983 - 1991

Math, English, Science, Computer Lab, Elementary Skills

Senior Landing Gear Design Engineering for the Y22 program Structural Design Engineering for F111, and F16 program Flight test Engineering- Burbank and Edwards Airforce Base Stress analysis Test lab Engineering

General DynamicsMissile Design Engineer

Pomona Missile Division Reviewed/modified as-built missile drawings.

GREGORY HARRELL2813 INGRAM DRIVE

GRAND PRAIRIE TX, 75052817-832-3309

harrellg@prodigy.nethttps://www.linkedin.com/in/gregory-harrell-b2731314

1880-1982

PROFESSIONAL TRAINING Professional Engineering (PE) Review (48 hours) Certified Quality Engineering (CQE) Review (40 hours) Landscape Irrigation Training (40 hours) Aseptic Cleanroom Certification QbD and CFD simulation and modeling ISPE - Water and Steam system training University of Tennessee Health Science Center– Post graduate

course in the Preparation of Parenteral Products CADAM (Computer Aided Design and Manufacturing) CATIA (Computer Aided Three-dimensional Interactive

Application) AutoCAD (2D/3D CAD design, drafting, and modeling) Intergraph (2D/3D CAD design, drafting, and modeling) Robotics (Design and programming) PLC /assembly language Visual Basic programming language C programming language C++ programming language Documentum & GMPharma document management system CMMS Preventative Maintenance Software (Blue Mountain) ISPE (International Society of Pharmaceutical Engineers) ASHRAE (American Society of Heating, Refrigerating and Air

Conditioning) PI Tau Sigma-National Engineering Honor Society Alpha Phi Alpha – National Social/Community Organization NSBE – National Society of Black Engineering LSIA – Lone Star Irrigation Association

EDUCATION BS in Mechanical Engineering Southern University - Baton Rouge Louisiana

Masters of Science in Mechanical EngineeringUniversity of Texas at Arlington (in progress-36 hours completed)

TCEQ-Texas Commission on Environmental QualityLicensed landscape irrigator