Gregory Davenport Email & Phone Number

Cary, Nc, Us

Senior Project Engineering Consultant with an extensive background in capital projects management and field execution for risk based pharmaceutical systems design, build and qualification. Specialized in CQV (Commissioning, Qualification, Validation), CSV (Computer Systems Validation), and Process compliance for Solid Dosage and Sterile environments. Versed in ASTM E2500 / GAMP 5 specifications related yo Pharmaceutical and Biopharmaceutical automated manufacturing and Medical Device equipment. VERSED IN• FDA cGMP• CFR Title 21; Parts 11, 210, 211, and 820 • EMEA• ASTM-E2500• ICH • SOX• GAMP5 • FMEA • CAPA• GERM• ISA-S88• OSHA 10 General Industry CertifiedQUALIFICATION ENVIRONMENTSComputers - Allen-Bradley Factory Talk , Honeywell BAS/BMS/SCADA, Siemens Insight, DeltaV, GE iFix , Allen-Bradley / Siemens PLCs, MES, SAP, and ERP applications; EDMS, LIMS, HMI / OIT software Data Historian, Custom and COTS software.Equipment – Aseptic Vail Fill, Solid Dosage Bottle Fill, Non-Sterile Bottle/Vail Capper, Label Maker, Cartoner, Vision Systems, CIP/SIP, Isolation/Containment Chamber, Single-Use and Fixed-Use Up and Downstream processes (BioReactor, Mixer, Chromatography, Filtration), Lab Processes, Media/Resin Filling, Jacketed Vessel, Compartment Washer, Vial Washer, Autoclave, Depyrogenation Tunnel, Freeze Dryer, Fluid Bed Dryer, Tablet Compression/Coating, Spray Dryers, , WBSO/FR (Water for Bulk Sterile Operations/Final Rinse), PW (Purified Water), WFI (Storage and Distribution), CSGs (Clean Steam Generators), HVAC, Particulate Monitoring, Utilities, PCA (Process Compressed Air), Nitrogen/Liquid Nitrogen, Medical Device (Class I, II, III).Client Projects List:Beatrice/MylanIllumina Genesis-AlkaliCigniti Technologies Ltd.Alcon (Novartis)Roche PharmaceuticalsMerckGlaxoSmithKlineNovartis GE Kremers Urban / UCBEli LillyPfizerPDL BioPharma Boehringer Ingelheim TevaSigma-Aldrich Par Baxter BioSciencebioMeriuexDiosynth

General consulting responsibilities at numerous large and small scale client sites in the United States encompassing complete cGMP life-cycle documentation generation of Validation Plans, Requirements Specifications, Design Specifications, Installation / Operation Qualifications, Performance Qualifications, and Validation Final Reports (VP, RS, DS, IQ/OQ, PQ, and VFR) for the qualification of Medical Devices, Computers, Controls, Processes, Equipment and Utilities.

Lead Technician on multiple Thermoformer Blister and Bottle Packaging lines. Guide a manufacturing team to perform production runs for site package designs to ensure compliance with internal and FDA packaging and identity criteria. Provide daily written lot compliance results.Thermoforming tools and forming equipment \ Bottling tools and bottling equipment \ Graphic printing associated with packaging equipment and materials (inks, coatings, etc) \ Packaging assembly process include manual assembly, blister pack heat, RF and other methods of sealing/tamper proofing retail packages \ Document complex packaging systems processes to troubleshoot quality and productivity concerns \ Contribute to the development and execution of qualification effort (Requirements and Test Protocols)..

Matricultion Information Systems (Computer Science Concentration)

Matriculation - Computer Science

Education record