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ISO 9001
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ISO 14001
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ISO/TS 16949
compliance
lean
enterprise
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GMP/ISO 13485 Compliance Energy Services principal
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Principal Consultants

Frank Yazhari
frank@fyconsulting.com
908-875-7466

Experience
Frank is the principal consultant for FY Consulting, which provides consulting and training services in ISO 9001, ISO 14001, ISO/TS 16949, AS 9100, ISO 13485, OHSAS 18001, Lean Enterprise, Six Sigma Improvement Methodology, Performance Excellence and Supply Chain Management to the process and service industries. He is a Certified Six-Sigma Black Belt professional with over 25 years experience. Frank holds a BS and MS in Chemical Engineering and is an ASQ Certified Quality Engineer and a RAB Certified Lead Quality Management Systems Auditor.


Yefim Katsov, PhD
908-875-7466

Experience
Yefim has been affiliated with FY Consulting since 2006 during which period he has been involved in comprehensive employee training and implementation of process improvements both manufacturing and service industries. Prior to his affiliation with FY Consulting, Yefim acquired an extensive experience in application of Lean and Six Sigma tools for process improvement at large commercial companies such as AlliedSignal/Honeywell and Tyco International.

Yefim is a Six Sigma Black Belt, a Quality Engineer and a Certified Quality Auditor. He earned a PhD in Chemical Process Pyrometallurgy from USSR Academy of Sciences and BS/MS in Process Metallurgy from the Moscow Institute of Steel and Alloys. Over the course of his industrial career he successfully managed multiple projects, both in Process Developments and Improvements. The latter is summarized in 43 published technical articles and 40 inventions


Mariesa Julien, Ed.D.
908-875-7466

Experience
Mariesa specializes in the implementation of lean Enterprise, Integrated Process Management, Process Improvement using the Six Sigma methodology, Project Management and Team Building. She not only brings the technical aspects of manufacturing, service provision and quality to her services, but industrial psychology as well.

She has been an assistant professor at Brookdale College, an instructor at the Manhattan School of Medical and Dental Technologies and an instructor at New York Medical College. Mariesa received her Ed. D. in counseling Psychology from Columbia University and her B.S. in Microbiology and Biochemistry from Colorado State University.


Vince Kranz
908-875-7466

Experience
Vince has over 30 years of experience in Consulting, State Government, and Manufacturing (power, aerospace, chemical process, and pharmaceutical). His work experience has been with Johnson & Johnson (Noramco Inc.), Rhone-Poulenc (Rhodia), AirWork, the State of Delaware, and several environmental consultants.

Vince has managed energy expenditures ($2.5MM/year) and developed energy conservation projects for a pharmaceutical manufacturing facility. He has conducted Greenhouse Gas surveys and developed energy reduction programs for manufacturing, warehouse, R&D, and office facilities. He has extensive experience in implementation of Environmental, Health and Safety Management Systems (ISO 14001, RC14001, RCMS, OHSAS 18001, OSHA Voluntary Protection Program, USEPA National Environmental Performance Track, and ChemStewards). Vince has a B.A. in Biology from La Salle University and an M.S. in Environmental Science from Rutgers University.


Gary Lehnus, PhD
908-875-7466

Experience
Dr. Lehnus has worked throughout his career in regulatory compliance and FDA submissions, and has over 100 FDA submissions for devices, diagnostics, biologicals, and drugs, from 510(k) to PMA and BLA and NDA submissions for clients. Dr. Lehnus has created clinical protocols, located and monitored study sites, and performed data analysis for a variety of analytical and clinical studies. Gary has created and established complete Quality Management documentation systems for companies to comply with ISO and FDA QSR/GMP regulations and performs GMP audits. He has a Ph.D. in microbiology and biochemistry.


Paul Moran
908-875-7466

Experience
Paul Moran has over 30 years experience in R&D, Quality Assurance and Quality Systems Improvement in Polymer Products, Medical Devices, Pharmaceuticals, Diagnostics and Consumer Products. He has worked with over 100 locations on GMP auditing, quality improvement and certification preparation. His career began at Yale Medical School in research and he spent 23 years with Johnson & Johnson in technical and management roles in technical services, quality assurance, and corporate quality systems improvement.

He has a BA in Chemistry from the University of Connecticut, and has been active in the American Society for Quality, including earning certifications in Quality Auditing, Quality Engineering and Quality Management.


Nick Scarpa
908-875-7466

Experience
Mr. Scarpa has over 25 years of experience in Manufacturing and Process Automation. Drawing upon Lean Manufacturing fundamentals, a strong Engineering Technology background and experience in the field of Quality Management Systems, Nick has led many process improvement efforts which have reduced waste, improved quality and increased production throughput. He has a Masters Degree in Engineering Management, Project Management Certification and B.S. in Engineering Technology from New Jersey Institute of Technology.


Jim Agalloco
908-875-7466

Experience
Jim has thirty years of management experience in pharmaceutical manufacturing, pharmaceutical engineering, computer systems validation, technical services and research and development. He is an internationally recognized expert on process and systems validation and has extensive knowledge of pharmaceutical and BPC manufacturing technology. Jim has an M.B.A. (Pharmaceutical Studies) from Fairleigh Dickinson University, an MS in Chemical Engineering from Polytechnic Institute of New York and a BS in Chemical Engineering from Pratt Institute of Brooklyn.


Rodney Richards
908-875-7466

Experience
Rodney Richards has over 35 years experience as a manager in NJ State government, both in energy and Information Technology. He established the State's first statewide contracts covering all departments, for both IT hardware and software services and maintenance.

He has over eight years experience managing the State's first Energy Office. He has developed and written the first state government Requests for Proposals for online Internet reverse auctions of energy supply, consulting services including energy auditing, solar supply and installation, demand response services, renewable energy supply, Green Tags and more. Rodney has managed state sales of Solar Renewable Energy Certificates on the open market. He has chaired many Evaluation Committees and reviewed innumerable bids. Rodney has extensive knowledge of state and municipal programs, processes and procedures. He studied Information Technology and Business Law in college. Rodney is a Certified Energy Procurement Professional by the Association of Energy Engineers.


Gregg Rackin
908-875-7466

Experience
Gregg has 23 years experience in Government Affairs and Public Policy. After obtaining his Master degree at Ohio University in 1986, he started Gregg A. Rackin & Associates. Clients included both non-profit and fortune 500 companies. In 1992, Gregg joined Merck as United States Human Health Director of Government Affairs and later as the Director of Public Policy until 2003.

Gregg was elected to serve as Mayor of the Borough of Stockton, New Jersey and during his four years in office, brought an unprecedented $3 million in funding to one of New Jersey's smallest communities. Gregg's experience with the for-profit, non-profit and government sectors of the economy helps clients to better navigate the maze of public programs, policies and extraordinary funding opportunities related to energy use.


Howard Liebermann, PhD
908-875-7466

Experience
Dr. Liebermann has over 30 years of experience in R&D and Manufacturing. Howard has extensive experience in implementation of Six Sigma/Lean methodologies used to identify and eliminate non value-added steps in processes and to improve productivity. While working at Allied Signals for 24 years, Howard was part of teams applying the Six Sigma/Lean principles to numerous customer-linked commercialization projects.

He is a Six Sigma Black Belt and has a Ph.D. in metallurgy/materials science and engineering from University of Pennsylvania.

 

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