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Founder, and Principal Engineer
John Hyde founded Hyde Engineering + Consulting in 1993 to serve the Pharmaceutical and Biopharmaceutical community. Prior to the formation of Hyde Engineering + Consulting, John was a Senior Project Engineer with a biopharmaceutical research and manufacturing company located in Boulder, CO.
His work included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm’s large scale and clinical manufacturing facilities. From 1982-1993, John was Manager, Process Systems Design with an engineering firm specializing in the design and start-up of pharmaceutical, dairy and food process systems and the application of CIP technology.
John has published and presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, cleaning and cleaning validation principles and practices, FDA compliance strategies, and control systems design for manufacturing processes. John served as a member of the PDA Subcommittee for Biopharmaceutical Cleaning validation and in this capacity he contributed two chapters to “Cleaning and Cleaning Validation, Volume 3”. John serves on the board of the Society of Bioprocess Professionals (SBP) and is a regular speaker at conferences sponsored by SBP, ISPE, PharmaConference, IVT, Microrite and other professional societies. He holds bachelor’s degrees in Food Science and Business Administration and a master’s degree in Food Engineering from Ohio State University.
Principal Process Engineer
Ronald Berk is the Chief Technical Officer at Hyde Engineering and Consulting. His responsibilities include the delivery and quality of all engineering projects executed by Hyde. Ronald joined Hyde in 1999 and has extensive experience in capital projects for biopharmaceutical, vaccine manufacturing, and fill-finish facilities. He is a subject matter expert in sanitary design and a member of the ASME BPE System Design Subcommittee.
Ronald’s design philosophy is to design a closed process using stainless steel reusable equipment and single-use equipment, as it fits the needs of the client. In addition to his depth of experience in design and project management, Ronald has served as an expert witness and consulted on complex litigation cases for large construction projects.
He graduated from the Higher Technical College Amsterdam with a Bachelor of Science in Chemical Engineering and a minor in Business Management.
Principal Engineer
Keith holds a Bachelor of Science degree in Chemical Engineering from the University of Colorado at Boulder. He began his career conducting government contract research in catalysts and advanced materials through SBIR grants. Following that, he joined Hyde Engineering + Consulting, Inc. in 1999 and worked in a variety of areas from control system development to cleaning validation.
Keith has provided high-level consultation to Hyde’s Engineering’s clients in topic areas ranging from strategic quality and validation documentation architecture to detail-oriented support such as design of experiments and supporting study design. He has expertise in the implementation of online TOC instruments and process analytical technologies for clean-in-place systems, as well as the translation of bench-scale cleaning process development data to full-scale manufacturing systems.
Leveraging this expertise, Keith founded Hyde’s Cleaning Process Development Lab in 2011, a facility devoted to the development, exploration, and scaleup of cleaning processes for the pharmaceutical and biopharmaceutical industries.
Keith has also published multiple journal and periodical articles as well as chapters in PAT Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality-by-Design by Duncan Lowe, and in Cleaning and Cleaning Validation, Volume 2, edited by Dr. Paul Pluta. Keith is currently an elected member of both the Board of Directors for the Rocky Mountain Chapter of ISPE and the Mountain States Chapter of the Parenteral Drug Association.
Keith is currently a member of the International Society for Pharmaceutical Engineering (ISPE), the American Institute of Chemical Engineers (AIChE), and the Parenteral Drug Association (PDA).
Principal Engineer
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Principal Engineer
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Principal Automation Engineer
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Principal Project Manager
Fearghal Downey brings with him over 22 years of experience working in the Pharmaceutical and Chemical Industries, and in research and development. He is a talented leader with a proven record of accomplishments in completing projects successfully in the areas of clean-in-place systems, process and clean utilities, containment, commissioning, and qualification. Fearghal has excellent management, analytical and decision-making skills with a proven ability to plan and manage teams.
Fearghal holds a Bachelor degree in Chemical Engineering from University College, Dublin, and a Ph.D. in Chemical Engineering from Cornell University. He is a Chartered Engineer and a Fellow of the Institute of Chemical Engineers. He began his career with Merck Sharpe and Dohme in Ireland within the Technical Operations group, specializing in preparing the facility for the introduction of new products and processes.
Since 1998, he has predominately been responsible for project delivery from both a technical and managerial aspect. He has delivered large scale projects from design, through construction, commissioning, and qualification in both the API and biopharmaceuticals areas. During this time, he developed core expertise in several areas such as high containment systems (powders and liquids), fluid and powder transfer systems, clean-in-place design and operation and sterile processing.
Fearghal joined Hyde Engineering and Consulting, Europe Ltd in September 2012 as Technical Director for the European Operation, while also providing specialized knowledge to the Global organization, particularly in his specialty areas and project execution. He has been collaborating with the Hyde Analytical laboratory since joining Hyde.
Fearghal is a very active member of the ISPE community and is currently serving his second year as Treasurer of the ISPE Ireland Affiliate and has been a committee member since 2010.
Principal Engineer
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Principal Engineer
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Principal Consultant
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Technical SME Europe
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Senior Engineer, Analytical Lab
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Principal Engineer, Analytical Lab
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Principal Engineer
Bioprocessing equipment and facility design, Facility modification and equipment installation in a validated environment, Purfied water / clean steam / Clean-in-Place (CIP) systems, Leading process engineering teams with A&E design firms, equipment fabricators, scientist collaboration
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Senior Scientist, Analytical Lab
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Principal Engineer
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Senior Engineer
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