Renee Buthe | Manager, Technical Service

Renee has over seven years of industry experience, specifically in cell and gene therapies. She has expertise in generating protocols for and performing environmental monitoring, airflow visualization studies and aseptic process simulations, reviewing batch records and authoring final reports. Renee holds a bachelor’s degree in biology.

At STERIS Life Sciences, Renee assists Customers with sterility assurance and sterility maintenance product applications.

Renee is currently an instructor through the Parenteral Drug Association (PDA) training institute and an active member of the association.

Matt Hofacre | Senior Director, Technical Services

Matt has over two decades of experience in pharmaceutical and biopharmaceutical production, advanced therapy medicinal product production, high containment, food and beverage, medical device and laboratory research industries. He holds a master’s degree in finance and marketing and a bachelor’s degree in chemical engineering.

For STERIS Life Sciences, Matt supports Customers globally with design applications, project maintenance and technical guidance for integrated Vaporized Hydrogen Peroxide (VHP), steam sterilization, washing, pure steam, water systems and services. He is a student of lean practices to maximize value stream to Customers.

The Parenteral Drug Association (PDA), the International Society for Pharmaceutical Engineering (ISPE) and the American Society of Mechanical Engineers (ASME) have welcomed Matt as a presenter and trainer at several national and international conferences.

Matt co-authored “PDA Technical Report No. 48 Moist Heat Sterilization Systems: Design, Commissioning, Operation, Qualification and Maintenance” and has contributed to numerous other articles on water for injection systems, VHP and pharmaceutical equipment selection.

Daniel Klein | Senior Manager, Technical Services

Dan has over two decades of industry experience, including working in research and development for microbiology and clinical affairs. He has also managed a contract testing laboratory. Dan holds a master’s degree in biology and a bachelor’s degree in microbiology.

At STERIS Life Sciences, Dan provides technical expertise to Customers and helps troubleshoot and solve contamination issues. He supports Customers with a variety of critical processes and general understanding of the latest developments in the industry. He frequently presents data and other information at international industry meetings and sponsored events.

Dan is an active member of ASTM International, the Association for the Advancement of Medical Instrumentation (AAMI), the Parenteral Drug Association (PDA), the Association of Official Analytical Collaboration (AOAC) International, the Institute of Environmental Sciences and Technology (IEST) and the Center for Biofilm Engineering (CBE). He previously served as Chairperson of the AOAC International’s Committee on Antimicrobial Efficacy Testing. He is an active participant in ASTM’s E35.15, E55.08 and D37 Committees and a primary member of AAMI Work Group 08.

Throughout his professional experience, Dan has authored numerous industry articles and book chapters in peer-reviewed journals related to disinfection and sterilization.

Juha Mattila | Director, Sterilization Technologies

Juha has over two decades of experience in pharmaceutical, research and biosafety technologies. He manages the STERIS Life Sciences portfolio of products for Vaporized Hydrogen Peroxide (VHP) and steam sterilization, material transfer biodecontamination technologies and water for injection and pure steam generation systems. He holds a master’s degree in business informatics and a bachelor’s degree in heating, ventilation and air conditioning (HVAC) and process engineering.

In addition to being an active member of the Parenteral Drug Association (PDA), the International Society for Pharmaceutical Engineering (ISPE) and the Finnish Biosafety Network, Juha has authored several technical articles and spoken at many industry events. He also contributes to the International Organization for Standardization (ISO), the European Committee for Standardization (CEN) and the British Standards Institution (BSI) work groups considering these technologies.

Juha provided commentary through the PDA for the European Union (EU) Good Manufacturing Practices (GMP) Annex 1 draft and participated in the PDA EU GMP Annex 1 Workshop.

Aaron Mertens | Senior Manager, Technical Services

Aaron has over two decades of experience in pharmaceutical manufacturing, with expertise in cleaning, disinfection, sterilization and contamination control. He has held several positions within the pharmaceutical industry, with experience working at pharmaceutical manufacturing organizations representing quality assurance programs and working with global industry regulatory agencies. He holds a bachelor’s degree in genetics.

At STERIS Life Sciences, Aaron performs global manufacturing site evaluations and consultations to ensure compliance with international regulations. He is also responsible for providing global technical support for critical environments, sterility assurance and sterility maintenance application and validation.

Aaron is an active member of the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE). He previously served as President of the ISPE Great Lakes Chapter and is currently on the chapter’s Board of Directors. He is also a member of the ISPE Sterile Products Processing Steering Committee.

Additional professional activities for Aaron include delivering technical content to the industry with posters, publications, virtual and live technical presentations, as well as leading global sterilization master classes.

Jim Polarine | Senior Manager, Technical Services

Jim has three decades of experience in cleaning, disinfection, microbial excursions and disinfectant validation and testing. He holds a master’s degree in biology.

Prior to joining STERIS Life Sciences, Jim worked as a Clinical Research Manager with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois.

A member of STERIS Life Sciences team for the past 23 years, Jim’s current technical focus is on microbial control in cleanrooms and other critical environments. He conducts on-site training, webinars and high-level technical support for Customers in the biopharmaceutical industry.

As a 2019 Parenteral Drug Association (PDA) Michael S. Korczynski Award recipient, Jim was recognized for his contributions toward the development of PDA's international activities. He has given lectures around the globe on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. He has also published several PDA book chapters and articles related to cleaning, disinfection and contamination control.

Jim currently serves as President of the PDA Missouri Valley Chapter and Technical Coordinator for the Institute of Environmental Sciences and Technology (IEST). He is also the current Membership Vice President of the IEST Executive Board. He is an active member of the International Society for Pharmaceutical Engineering (ISPE), the American Society for Microbiology (ASM), the Society for Industrial Microbiology and Biotechnology (SIMB) and other industry associations.