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LITIGATION SUPPORT SERVICES


CENTER FOR RAPID RESPONSE ENGINEERING® SOLUTIONS

ENGINEERING AND SCIENTIFIC CONSULTING SERVICES

Resume of LGC
Consultant

EXPERTISE AND SERVICES

Packaging Expert Consultant
Expertise in product packaging, package design, package development, setup component inventory, multilingual technical documentation, package testing, component inspection, and package validation.

Specialization includes material sourcing, equipment validation, vendor sourcing, vendor approval, external customer interface, internal customer interface, design control, multilingual labeling, management skills, team development, lab testing equipment, design control, quality control, process control, ISO 9001:2000, ISO 13485:2003, ISO 17025, ISO 14791, and QSR 21CFR Part 820.

This KKAI Associate offers expertise specific to fabrication machines, packaging components consolidation, process quality, process yield, productivity, cost effectiveness, and quality assurance standards.

Additional experience and specialization includes shock, vibration, drop and compression testers, and seal strength testers, densometer with photoelectric timing attachment, vacuum sealer, hot bar sealer, tray sealer, induction sealer, electro impulse sealer, IR spectrometer, analytical balance, hydraulic die cutter, sample cutting press, burst tester, torque tester, ink rub tester, vacuum tester, vacuum oven, micrometer, incubator, Pantone color viewing light, environmental chamber, and environmental oven

PRINCIPAL INDUSTRIES SERVED
Biological, Medical, Pharmaceutical

EDUCATION
Rochester Institute of Technology, Rochester, NY

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing packaging engineering consulting, failure analysis, forensic engineering and related expertise to a wide variety of clients.

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Case Studies

Packaging Engineer II, Applied Materials, Austin, TX

Supported product development at the Austin Facility, designed and implemented primary, secondary and tertiary packaging including responsibility for all necessary supporting documentation.

Packaging Engineer II, Sulzer Orthopedic, Biologic Division, Austin, TX

Sole packaging Engineer supporting the product development facility in Denver, CO, as well as facilities in Switzerland, California and Minnesota. Interfaced with surgeons from the U.S., Germany and Switzerland. Designed and began development of sterile primary and secondary packaging as well as multilingual labeling for an environmentally sensitive product.

Packaging Engineer, Alpharma Pharmaceuticals Division, Baltimore, MD

Sole Packaging Engineer supporting all projects at both Baltimore facilities and the facility in Lincolnton, NC consisting of 23 projects and 700+ employees, designed and developed primary and secondary packaging.

Packaging Engineer, Cordis, A Johnson and Johnson Company, Warren, NJ

Sole Packaging Engineer supporting all projects at Warren NJ site consisting of 800+ employees. Worked to redesign packaging for the Netherlands facility, and develop a package design to be used on a corporate wide basis, designed and developed primary and secondary packaging.

ADDITIONAL EXPERIENCE

Experienced with validating and qualifying fabrication machines and lab testing equipment.

Minimized inventory and reduced cost through consolidation of packaging components, sole packaging support to a 1.7 billion company.

One of eight member team supporting a 5.1 billion company responsible for the design and implementation of new packaging components, create technical documents for specifications, processes and procedures, assist in layout of multilingual instruction booklet.

Systematically improved quality of packaging components by developing and implementing incoming Inspection procedures
Developed and implemented vendor part inspection, quality checks and material and component handling procedures to ensure quality requirements were met.

Established procedures and supervised packaging assembly resulting in enhanced and sustained process quality, yield and productivity and cost effectiveness.

Set Quality Assurance standards for all packaging components and supervised manufacturing of packaging components for high tech, medical device, pharmaceutical and biological material industries
Reduced inventory cost with improved inventory control system
Evaluated new and existing materials and components to maximize cost savings.

Assisted in planning and implementation of a development lab to include sourcing and purchasing qualifying and validating equipment, lab procedures and setting up log books for each piece of equipment including shock and vibration, drop and compression testers, seal strength testers, densometer with photoelectric timing attachment, vacuum sealer, hot bar sealer, tray sealer, induction sealer, electro impulse sealer, IR spectrometer, analytical balance, hydraulic die cutter, sample cutting press, burst tester, torque tester, ink rub tester, vacuum tester, vacuum oven, micrometer, incubator, Pantone color viewing light, environmental chamber and environmental oven.

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

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Following are links to the resumes of a select few of many KKAI Consultants, Engineers and Experts with related expertise.

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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

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