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 a global engineering resources organization of more than 200 employees. Her responsibilities include the strategic direction of the management team, global operations and overseeing the attracting, developing and retention of talent to enhance 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 exponential in understanding all the moving parts of operational oversight.
As a hands-on 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 collaborative culture and exceed client expectations while continuing to invest in the industry’s foremost engineering professionals. She intelligently manages and empowers the organization to embrace the 5 Hyde values; Family, Integrity, Respect, Wisdom, Adventure.
Kerren holds a Bachelor of Arts and Master’s in Education from the University of California, Los Angeles (UCLA). She is Past President of the International Society for Pharmaceutical Engineering – Rocky Mountain Chapter (ISPE-RM), as well as a member of the Society for Human Resource Management (SHRM). In her spare time, Kerren enjoys spending time with her two daughters, 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.
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 is a graduate of University College Dublin and the Smurfit Business School, Ireland.
Ronald Berk joined Hyde Engineering + Consulting in 1999 and is the Chief Technical Officer. His responsibilities include the delivery and quality of all engineering projects executed by Hyde E+C. Ronald has extensive experience in capital projects for biopharmaceutical, vaccine, and fill-finish manufacturing facilities.
Ronald is a subject matter expert in sanitary design and is a member of the ASME BPE System Design Subcommittee.
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.
Ronald graduated from the Higher Technical College Amsterdam with a B.S. in Chemical Engineering with a minor in Business Management.
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.
Keith Bader has nineteen years of experience with specific expertise in project engineering, aseptic process engineering, cleaning process development, and validation, cleaning reviews and gap assessments as well as Pre-Approval Inspection (PAI) Readiness.
Through the years, he has provided high level consultation to Hyde’s engineering 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. Keith has focused in recent years on the implementation of online instrumentation 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 CORE Lab in 2012, a facility devoted to the development, exploration, and scale up 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.
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 re-joined Hyde in 2020 as VP of Global Engineering. He brings over two decades of experience from working at senior levels both in the US and in India with major engineering-consulting as well as pharmaceutical/biotech companies. Sanjay is a SME 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 16 years in the US starting in 1994. He joined a large international engineering firm and later moved to major biotech/pharmaceutical companies. He worked from ground up in various technical and management positions in the US at Kvaerner (John Brown), 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 holds MS in Chemical Engineering from the University of Akron, Ohio and BE 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.
Jeff is the Director of Canada Operations for Hyde Engineering + Consulting, Inc., recruiting, onboarding, and leading engineering teams to deliver expert customer service to biopharmaceutical facilities and the pharmaceutical manufacturing industry throughout the country.
Always creating opportunities, Jeff prides himself in not only hiring for specific jobs, but also in finding the right jobs for good people. A truly active listener, he knows when to ask the right questions. When it comes to leadership, Jeff takes a team based approach. He is a resourceful and deliberate networker and manager, sharing that his role is to make the employees the true stars of the organization. Moving forward, Jeff is advancing Hyde’s influence in Canada, presenting their true expertise in bioprocess engineering and validation.
One of the steppingstones that lead Jeff to Hyde’s management team was starting and partnering in a process engineering company for the biotech industry. With comprehensive experience ranging from conceptual through detailed design, vaccines, polyclonal antibodies, plasma fractionation, fill finish, OSD, API and Potent API, his contributions are many. His colleagues proclaim that if Jeff had a superpower, it would be his ability to quickly evaluate a chaotic situation, make sense of it and develop a team to deliver the project.
Jeff loves that ‘adventure’ is a Hyde core value! One of the best experiences of his life was when he and his wife moved to France when their kids were young and didn’t speak the language. He looks forward to fanning the flames of more adventure over the next few years and encourages his young recruits to expand their geographic horizons. Jeff holds a Bachelor of Applied Science degree (BASc) in Chemical Engineering from the University of Waterloo, Ontario, Canada. In his leisure time, he enjoys playing, coaching and refereeing hockey and says of refereeing, “it’s like paid exercise”.
As the 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 is an experienced Biotechnology Engineer. He started his career with Analytical Lab and then moved to Downstream Processing, where he worked in Sterile Filtration and Filter Validations. After having worked in the Aseptic Process area, he moved into Validation of Terminally Sterilized products. Trained in the USA, Ankur worked on Sterilization Validation, Terminal Sterilization, D Value Study of Parenteral, Sterilization GAP Analysis, and Sterilization Process Optimization.
After having worked in Validation, Ankur moved into the field of Commissioning and Qualification, wherein he worked as a Project Quality Manager for Fill Finish and Biotech facility for the C&Q of the same. He has also worked for a large Vaccine client for their C&Q project and a Switzerland MNC API C&Q project. Ankur is heading CQV projects across ASIA for OSD, Biotech, API facilities.
Ankur has been involved in GMP Gap Assessment, has been a trainer for GMP as well as Qualification and Validation. He has led the implementation of Risk-Based and Hybrid Approaches for many projects, was briefly involved in the task force for Control Strategy, and has developed a Risk-Based Strategy for Process Support systems.
Ankur has presented at ISPE Conferences and CPHI in India.
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 Western States Operations Director within Hyde and brings over twelve years of experience in the industry. David has worked on projects in Ireland and the US. He has a broad range of experience ranging from construction to validation in the fields of waste water treatment, pharmaceutical/biotech, and cosmetics.
David joined Hyde in May 2015 and has worked for a number of different clients in the fields of commissioning & validation. In his most recent project, David was responsible for establishing and managing the cleaning validation program for a client in the Northern California region. David was also the first Staff Manager in the region and during this time, he worked with the Hyde management team to help define the role and responsibilities.
Prior to joining Hyde, David worked with a number of different consulting firms and held a fulltime position for one year with Merck, Westpoint, Pennsylvania. In this role, David supported manufacturing of the chicken pox vaccine. However, David realized that he preferred the consulting field and left Merck to rejoin the world of consulting. Over the years, David has gained extensive knowledge in constructing and commissioning of large-scale pharmaceuticals and has extensive validation experience in the pharmaceutical/biotech and cosmetic industries.
David holds a BS in Mechanical and Manufacturing Engineering from Cork Institute of Technology and has a MS in General Systems Engineering from Walden University.
Pankaj is an experienced Project Manager with more than two decades of experience managing Global and Indian projects. He brings extensive work experience in active pharmaceutical, biopharmaceutical and oral solid dosage business verticals for leading organization across India and Canada. Pankaj has executed multiple domestic and international projects for successful completion on time within budget with total customer satisfaction.
As Certified Project Management Professional with Chemical Engineering background with diversified work experience in pharmaceutical field, he will definitely ensure Hyde team to reach its goal in well focused direction.