project engineering and laboratory programming expert consultant
Resume of YJJ, P.E. Consultant

  • Heating, Refrigerating, and Air-Conditioning
  • Construction
  • Electrical
  • Life Sciences

This expert has a B.S. in Chemical Engineering from the Illlinois Institute of Technology in Chicago, IL.

Project Engineering and Laboratory Programming Expert Consultant

This expert is a registered professional engineer with expertise in laboratory design and construction and the heating, ventilation and air conditioning requirements (HVAC) specific to laboratories. This expert is skilled in trouble-shooting problems and developing options for corrective actions. This consultant has designed air handling systems for new and remodeled laboratories. This person is also experienced with specialized facilities such as fermentation labs, nuclear magnetic resonance (NMR) labs, and microbiology labs.

Furthermore, this expert is experienced in pharmaceutical facility design and construction in accordance with applicable Food and Drug Administration (FDA) regulations. This expert's experience includes specified washing, filling labeling and packaging equipment for an aseptically-filled small volume parenteral (SVP) product; and this expert supervised the installation and validation of the equipment. This consultant designed a reverse osmosis water system for a pharmaceutical pilot plant and completed the installation and operational qualifications required to validate the system. Also, this expert wrote a protocol for sanitizing a deionized (D.I.) water distribution system, supervised the sanitization process, and wrote a final report detailing chemical and microbiological test results.

This consultant has expertise in designing and executing temperature mapping studies for equipment such as freezers, coolers, stability chambers, controlled environment rooms, autoclaves and sterilizers.

In addition to above, this expert has prepared and executed installation and operational qualification (IQ / OQ) protocols for walk-in freezers, reach-in freezers, and ultra-low temperature freezers. Also, this expert developed and validated a sterilization cycle for waste products that contained recombinant DNA.

Consultant, Kevin Kennedy Associates, Inc.

Providing consulting services related to facility design and construction, project engineering, and laboratory programming to a vast variety of clients.

President, engineering company

Consulting services focusing on laboratory programming, facility design and construction management, and equipment installation and validation Representative projects have included: Laboratory Programming and Remodeling: Developed several options for remodeling existing laboratory space into new laboratories, manufacturing room and office space. Reviewed options with client and, after finalizing the layout, redesigned the existing HVAC system to accommodate the new layout. Stability Chamber Validation: Developed IQ/OQ protocols for controlled environment chambers, executed protocols, and prepared final report. HVAC Survey and Analysis: completed a comprehensive testing program of the HVAC system in a four-story laboratory building. Identified the problems with the system, developed several options for corrective actions, including budget cost estimates for each option. Pharmaceutical Filling Line: Wrote Validation Master Plan for the installation of a pharmaceutical filing line. Developed and executed the IQ and OQ protocols for the equipment and wrote the final report Biological Containment System: designed, installed and validated a containment system for a laboratory involved with recombinant DNA work. Sterilizer Evaluation: used engineering studies to determine possible causes for validation failure. Made modifications based on the results of these studies and completed a successful validation. Reverse Osmosis Water System: calculated required capacity of system, supervised installation, and validated a reverse osmosis water system consisting of a water softener, storage tank pumps, mixed bed demineralizers and the reverse osmosis unit. Freezer Temperature Mapping: .Prepared a technical white paper on the effect of freezer loading on freeze times to answer concerns raised by a European regulatory agency. In-Line TOC Analyzer Installation: Assisted client in selecting a TOC meter for in-line installation in an existing RO system. Coordinated the installation and testing of the meter.

Senior Project Engineer, Becton Dickinson &Co., Skokie,IL

Senior Project Engineer, Searle Laboratories, Inc., Mount Prospect, IL

Process Engineer-Research and Development, Eschem, Inc., Oak Brook, IL

Project Engineer, Baxter Laboratories, Inc., Morton Grove, IL

Prepared a technical white paper on the effect of freezer loading on freeze times to answer concerns raised by a European regulatory agency.

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