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.
As CEO of Hyde Engineering + Consulting, Inc., Kerren Bergman leads this global engineering organization of more than 250 employees. Her responsibilities include strategic direction, global operations, and overseeing the development and retention of talent to ensure the growth of Hyde’s diverse and inclusive organization.
Kerren began her career with Hyde in 1998, advancing with the company in various roles of increasing responsibility. Her experience in nearly every aspect of the business including Operations, Business Development, Human Resources, Quality, Safety, and IT has been essential to understanding all the moving parts of organizational oversight.
As a servant leader, Kerren guides Hyde by cultivating an ‘attitude of gratitude’. She is driven, collaborative, visionary, and passionate about people. Kerren embodies Hyde’s mission to foster a culture of excellence to exceed client expectations while developing the industry’s foremost engineering professionals. She empowers the organization to embrace the 5 Hyde values: Family, Integrity, Respect, Wisdom, and Adventure.
Kerren holds a Bachelor of Arts and Master’s in Education from the University of California, Los Angeles (UCLA). She is the Past President of the International Society for Pharmaceutical Engineering – Rocky Mountain Chapter (ISPE-RM), and is a SHRM Senior Certified Professional. Her life balance includes spending time with her two daughters, enjoying the fresh mountain air in Colorado, singing, playing violin and piano, and kickboxing.
As the Chief Financial Officer, Adolphe oversees all aspects of the company’s global finance and accounting. Adolphe is a Certified Public Accountant (CPA) since 2007.
Before joining Hyde, Adolphe was a consultant at large public accounting firms, primarily focusing on providing transaction advisory services to clients. Adolphe spent four years at a large private equity firm where he was involved in investment screening, deep-dive financial and operational due diligence, and delivering operational enhancement to portfolio companies. Adolphe has years of experience in public accounting, providing focus on financial statement auditing services, and other attest engagements to both public and private clients operating in a variety of industries and sectors
Kalpesh Patel joined Hyde Engineering + Consulting in 2005 as an Engineer I. His expertise includes CIP, SIP, cleaning validation programs, commissioning qualification, and project management. He has extensive experience in biopharma and vaccine manufacturing start-ups, Qualification of Process Equipment and Utilities, cycle optimization, and troubleshooting for CIP and COP systems.
Kalpesh had a quick progression with his career at Hyde. He started supporting as a Project Manager, then Site Lead, Regional Manager, Director of U.S. Operation, V.P. of International Operations, and now recently appointed as Chief Operating Officer. Within this career, he has provided strong leadership in building partnerships with global clients. As a successful entrepreneur, Kalpesh has led multiple efforts to expand Hyde to serve new geographies internationally.
Before joining Hyde, Kalpesh worked with International Medication Systems Ltd. as a Validation Engineer, gaining extensive knowledge and experience related to various aspects of validation activities. Early on in his career, Kalpesh worked as a research assistant and developed a tissue fatigue tester (medical device) using Pro/E modeling software to evaluate the strength and lifecycle of bioprosthetic heart valve materials.
Kalpesh received a B.E. in Chemical Engineering from NIT Surat, India, and an M.S. in Chemical and Biomedical Engineering from Cleveland State University, OH.
Will joined Hyde to launch the Hyde Europe affiliate in 2010. As Managing Director of Hyde Europe, Will brings over 25 years of leadership in the global pharmaceutical and biopharmaceutical markets. His expertise is in large-scale project delivery, business development, and commercial management. Will is responsible for the start-up and ongoing development of Hyde’s business in Europe. He is also a Board Member of the Global Hyde organization and has served the company in leading a Global Strategy and Business Development role in the past while spending time across Hyde’s US offices.
Before joining Hyde, Will was Vice President and Director of Major Projects in Europe for a large international engineering firm. He had management responsibility for business development, staffing, and delivery of major projects for several business lines across offices in Ireland, the U.K., France, Germany, Italy, Spain, Belgium, Denmark / Sweden, Holland, Poland, and the Middle East.
Will has held several senior positions, including Regional Director and Business Development Director. He has contributed to many of the major pharmaceutical projects in Europe over the past 25 years. His primary activities include planning, managing, and implementing engineering, validation, compliance, and quality processes for large pharmaceutical organizations.
Will provides guidance, leadership, and support for process performance excellence and continuous improvement. Will holds a Bachelor of Arts from University College Dublin; and a Masters in Business from the UCD Smurfit Graduate Business School, Ireland.
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.
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).
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 CORE 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.
Sanjay Shah is the Vice President of Global Engineering for Hyde. He brings three decades of rich technical and management experience working at leadership levels in the US and India, with prominent pharmaceutical/biotech companies and engineering/consulting organizations. Sanjay is a Subject Matter Expert in conceptual & detailed design, process engineering, process automation, commissioning & qualification, process debottlenecking, strategic infrastructure planning & capital projects, technology transfer, and process safety management. He adds significant value to Hyde’s clients based on his rich experience spanning engineering & technology, operations, and compliance.
Sanjay spent over 16 years in the US starting. He joined Kvaerner John Brown, a large international engineering firm, and later moved to major biotech companies. He worked at Amgen, PS&S, and Eli Lilly (ImClone). As an Associate Director of Process Engineering at Eli Lilly in New Jersey, Sanjay supported large-scale biopharmaceutical projects. He relocated to India in 2010 and joined Dr. Reddy’s Labs as Director, responsible for setting up the Plant & Process Engineering Department. He later worked as Director & Head of Biologics operations at Syngene and then as VP and Head of Manufacturing Operations & Site Engineering at Intas, supporting the biopharma and plasma drug substance and sterile drug product operations. Sanjay worked as VP and Global Engineering Leader at Pfizer, supporting their sterile injectables network before re-joining Hyde.
Sanjay holds his Master of Science in Chemical Engineering from the University of Akron, Ohio, and his Bachelor of Engineering in Chemical Engineering from Maharaja Sayajirao University of Baroda, India.
Frank is the Financial Director for Hyde Engineering and Consulting Europe Limited. Frank joined Hyde Europe in 2010, and he is responsible for leading the financial and administration functions in Europe. Frank is an accountant and over his career he has held a number of senior positions with mutli-nationals and large hedge funds. In recent years, he had specialized in helping US firms setting up business in Europe, where he provides advise on local taxation, banking and compliance issues.
As the Senior Director of Global Recruiting, Karrie is responsible for setting the strategic direction for recruitment and brand messaging for Hyde Engineering + Consulting. Hyde’s global recruiting department champions our culture by working to attract and retain the best and brightest engineers in the biotechnology and pharmaceutical industry.
Karrie brings extensive technical experience to her role. She started her recruiting career in Colorado, specializing in sourcing and recruiting BS, MS, and Ph.D. scientific professionals for the pharmaceutical, biotech, chemical, oil & gas, food, and environmental industries. Before recruiting, Karrie was responsible for managing the sales of small to large-scale, in vivo and in vitro, monoclonal antibody production under cGMP and research guidelines.
Karrie holds a BS in Biology from the University of Wisconsin – La Crosse, and in her free time, enjoys spending time with her family and friends. She maintains balance in life by competing in triathlons and ultra-running. She has completed two 50-mile ultra’s (trail running) and is a 2-time Ironman finisher.
Jared Burke joined Hyde Engineering + Consulting in 2006 as a Computer Technician I.
In his current role as Director of Information Technology, Jared is responsible for all corporate information systems and hardware within the company.
Jared contributes extensive experience in implementing and administering systems throughout the organization. As the company has grown substantially, his role has expanded to supporting six regions across the US, as well as international offices in India, Europe, and Singapore. His great work ethic and collaboration with other department leads ensures system stability and functionality throughout the organization. Jared serves as an active member of many of Hyde’s internal structure committees.
Ankur Verma has extensive experience in the Biopharmaceutical and Pharmaceutical industries. He has supported Commissioning & Qualification (C&Q) projects as the Project Quality Manager/Project Head and Subject Matter Expert for Greenfield and Brown Field projects in India, Malaysia, the USA, and the EU.
Ankur’s key skills are strategy-making for C&Q based upon Traditional and Risk-Based approaches. His expertise also includes Design Reviews, Risk Management and Assessments, Commissioning & IQ/OQ protocol preparation, resource planning, project tracking, Work Breakdown Structure & LOD tracking and Paperless Validation.
He has previously worked with large Engineering and Consulting firms, Bioprocess solution firms and Sterilization and Terminal Sterilization Validation pioneer firms in the USA. Ankur presented at CPHI First Conference on Sterilization in India (2012) and the ISPE Conference in Bangalore / 2019 ISPE South Asia Pharmaceutical Manufacturing Conference, “Conundrum Entailing the Approach to C&Q of Facilities”.
Tanner realized his passion for Human Resources and Organizational Development during his Organizational Psychology coursework when obtaining his B.A. in Psychology from San Diego State University.
Following his career interests in Human Resources, Tanner now holds an M.S. in Strategic Human Resource Management from the University of Denver as well as the following HR certifications: Global Professional in Human Resources (GPHR) and Professional in Human Resources (PHR) through the Human Resource Certification Institute, Senior Certified Professional (SHRM-SCP) through the Society for Human Resource Management, and Certified Employee Benefit Specialist (CEBS) through the International Foundation of Employee Benefit Plans and the Wharton School of the University of Pennsylvania.
When he’s not immersed in studies or work, Tanner enjoys skiing and backpacking in the beautiful Rocky Mountains. Tanner’s interests in culture drive his passion for international travel and business. He enjoys volunteering in local communities and is an advocate for wellness and self-improvement.
Tanner is enthusiastic about the role HR plays at Hyde. Hyde’s HR department serves to support the success of all employees aligning individual career goals and contributions with organizational goals. Hyde’s philosophy is to offer meaningful work and financially rewarding career opportunities for employees while creating a culture of teamwork and collaboration.
David is the Vice President of United States Operations. He is an accomplished and goal-oriented professional offering more than 17 years of Small Molecule and Biotech experience spanning the construction of green field facilities to the commissioning and validation of various utilities and process equipment. He has worked in wastewater and nutraceutical facilities. David’s solution-oriented approach effectively achieves optimal results while building strategic alliances. He is a dynamic, diplomatic leader who inspires and authentically develops productive relationships with employees and clients. David organizes and drives operations, provides oversight and project management support, and consistently exceeds client expectations.
David joined Hyde in 2015 and supported multiple clients in the fields of commissioning, qualification & validation. As a Site Lead, David was quickly promoted to Staff Manager for the region and eventually promoted to Regional Manager for California. David’s responsibilities expanded to oversee the Central region, and in 2022, he was promoted to Director of U.S. Operations.
David started his career in the construction and startup of a Waste Water treatment facility (removal of APIs in the water) in Ireland and in 2007, he took the opportunity to move to the US. Over the years, David gained extensive knowledge in constructing, commissioning, qualification, validation, and management in the pharmaceutical/biotech and alternative industries (Food, CBD, Nutraceuticals).
David graduated with his bachelor’s degree in Mechanical Engineering in 2005 in Cork, Ireland, his first master’s in general systems in 2013, and received his Master of Business Administration in 2022.
Pankaj is an experienced Project Management Professional with more than two decades of experience managing Global projects. He brings extensive work experience in active pharmaceutical, biopharmaceutical, and oral solid dosage business verticals for leading organizations across India and Canada. Pankaj has executed multiple domestic and international projects for successful completion on time and within budget with total customer satisfaction.
As a Certified Project Management Professional with a Chemical Engineering background with diversified work experience in the pharmaceutical field, Pankaj ensures the Hyde team reaches its goals in a well-focused direction.