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Resume of MGY
Consultant
EXPERTISE AND SERVICES
Biopharmaceutical Engineer, Mechanical Engineer, Engineering Design and Process Engineering, Validation, Consultant, Specialist, Forensic Analysis Investigation Expert Witness Testimony, Engineering Consulting ServicesExpertise in engineering design/project management, cGMP manufacturing, R&D Labs, management of process and project engineers, execution of capital projects for process systems, equipment and facility projects from conceptual design through commissioning/validation, final product quality targets, methodologies and innovative solutions, and pharmaceutical manufacturing.
Extensive knowledge regarding plasma testing, design and installation of aseptic fill suites, vial washers, depyrogenation tunnels, filling equipment, Lyophilizers, purified and WFI water systems, bulk process reaction vessels, protein separation equipment, sterile filtration, fill and finish of liquid and lyophilized products, CIP, COP and SIP systems, and validation requirements.
This KKAI Associate offers expertise specific to equipment installation and start-up of process equipment for media mixing, design and installation of supporting process utility piping systems for cooling towers, chilled water, RO, WFI/CWFI, clean steam, bulk transfer of sterile liquids, cappers and pasteurizers, clean room systems, environmental compliance, bulk process of foods and detergent manufacturing
PRINCIPAL INDUSTRIES SERVED
Biotechnology, Food Processing, Pharmaceuticals
EDUCATION
B.S., Mechanical Engineering, Heald Engineering College, San Francisco, CA
Additional Training:
State of California EIT
Professional Development:
Project /Design/Construction Management Training Seminars
Good Manufacturing Practices seminars and continuous in-house training on cGMP
Capital Equipment accounting and Manpower Budgets
Training in ISO-9000, cGMP, EPA, FDA, OSHA, ASHRE regulations and procedures
Project Management Training Seminars
Core Skills for Building Commitment, Managing Through Change, Delegating for Productivity, Leadership: Facilitating Change
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing project management, biopharmaceutical engineering, mechanical engineering, engineering design, process engineering, validation expertise and consulting to clients in a wide variety of industries.
Speak to this experienced, world-class expert now.
- Call (317) 735-7121
- E-mail mgy@rapid-response-consulting.com
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Manager/Process Engineering, Consultant, Plasma Therapeutic Manufacturing Facility
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Managed Process Engineering group for a Plasma therapeutic manufacturing plant of 775,000 sq. ft of cGMP manufacturing space, R&D Labs, physical plant, warehouse and office space. Managed a staff of 25 process and project engineers, while providing leadership in the execution of capital projects involving process systems, equipment and facility projects from conceptual design through commissioning/validation while meeting budget, schedule and final product quality targets. Projects included design and installation of aseptic fill suites, vial washers, depyrogenation tunnels, filling equipment, Lyophilizers. Design and installation of Purified and WFI water systems, eliminating operation bottlenecks in parenteral manufacturing. Designed and installed bulk process reaction vessels, protein separation equipment, sterile filtration, fill and finish of liquid and lyophilized products, CIP, COP and SIP systems which increased plant manufacturing through put by 30%. Designed and installed class 100 through 100,000 processing suites. Design/installation of refrigeration process utility support systems for low temperature Kohn Fractionation processing. Established procedures for better interfacing of process controls – PLC/HMI, SCADA systems utilizing GAMP, with 21 CFR, Pt. 11 compliant approach to systems Validation requirement. This provided improved inter-reaction between Engineering and Validation groups, eliminating deficiencies in the release of projects to Validation as well as avoid discovery during execution of protocols.
Principal, Pharmaceutical Engineering Consultant, DB & Associates, Diamond Bar, CA
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Managed engineering design, equipment installation and start-up of purified water and process manufacturing systems, process equipment for media mixing, filtration and filling. Design and installation of supporting process utility piping systems for Cooling towers, Chilled water, RO, WFI/CWFI, Clean Steam, CIP/SIP systems. Provided validation IQ, OQ / PQ protocol documentation, conducted field executions for in process systems and turn over packages to client. Developed and executed process system design, construction documentation, installation and GMP validation of Bulk transfer of sterile liquids; class 100 to class 100,000 clean rooms and Sterilization, Lyophilization, Sterile filtration, vial washers, cappers and pasteurizers.
Project Manager, Fluor Daniel Corporation, San Francisco, CA
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Managed multiple engineering projects in the Bio/Pharm engineering division, including project design engineering, schedule, cost, and equipment start up/validation. Managed Clinical Manufacturing Build-Out expansion, provided team leadership for the design of multi-product clinical manufacturing facility, consisting of Media preparation, Fermentation, Recovery and Purification suites. Managed and coordinated Validation Master plan for the Baxter Filling Upgrade 2.2 project. Prepared and executed protocols for Steam Sterilizers, Vial Washers and Clean Rooms.
Director of Project Engineering, Alpha Therapeutic Corporation, Los Angeles, CA
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Was responsible for project and plant engineering functions including ten Engineers, three CAD Designers and Administrative Assistants in a 1,200 people, 160,000 sq.ft. Manufacturing plant site. Managed and led engineering projects from conception through completion to support $400 million product manufacturing. Developed and implemented site capital plan for engineering budget also project life cycle for all site projects. Led, coached and developed a staff of Engineers. Managed plant process, utility and environmental compliance functions. Identified, managed and implemented capital projects for new Bio-Testing Laboratory in Memphis Tenn. Increased plasma testing capabilities by 150%, new 31,000 sq.ft Plasma Manufacturing Facilities, process Equipment for Production Requirements, increasing raw material thru-put by 40%, integration of Equipment into Space Planning, improvement in cGMP spatial requirements, long range planning for manufacturing process and utility systems for new products. As project engineering manager, managed the Project/Process Engineering in the Corporate Engineering Department. Project engineer responsible for implementing process engineering projects, generated user requirements, design specifications, coordinated design and led installation of major equipment, process and utility systems for bulk processing and fill and finish manufacturing. Installed HVAC clean room systems, Autoclaves, reaction tanks, Fillers, Vial and stopper washers and Lyophilizers. Projects were implemented to improve plant productivity initiatives.
Senior Project Engineer, Lever Brothers Company, Los Angeles, CA
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Managed engineering design, specifications, implementation of projects supporting bulk process of foods and detergent manufacturing.
Plant Engineering/Design Engineer, Ford Motor Company, Los Angeles, CA
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Managed site infrastructure and utility engineering projects for automobile assembly plant.
ADDITIONAL EXPERIENCE
- Liaison with governmental agencies
PROFESSIONAL AFFILIATIONS
Member, International Society of Pharmaceutical Engineering
Member, ASME
Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.
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| Resume of RIW | packaging engineer, management, engineering, engineering failure analysis, accident reconstruction consultant, specialist, forensic analysis investigation expert witness testimony, engineering consulting services |
| Resume of IFT | mechanical and manufacturing engineer, design for manufacture and assembly consultant, mechanical systems design consultant, new product introduction, process improvement, engineering failure analysis, accident investigation, accident reconstruction, specialist, forensic analysis, investigation, product liability, expert witness testimony, patent infringement, expert witness testimony, engineering consulting services |
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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax