Kristen Riley is a seasoned engineering and operations leader with more than 30 years of experience spanning biopharmaceutical component testing, project management, workforce development, business strategy, and process safety engineering. She brings a rare combination of technical depth, operational leadership, and refined interpersonal communication — grounded in professionalism, organization, and meticulous attention to detail.
Kristen currently serves as Project Engineer at The BioProcess Institute, where she leads business development and directs complex testing programs for major pharmaceutical manufacturers and component suppliers. She oversees projects from protocol development through laboratory execution, data interpretation, and final reporting. Her work focuses on fitness-for-use testing under simulated process conditions, extractables studies, failure and root-cause investigations, and interpretation of analytical results in alignment with ISO, USP, and FDA standards. She specializes in both multi-use and single-use systems, helping clients select appropriate materials to achieve optimal product quality and process performance.
In addition to her technical leadership, Kristen designs and delivers GMP-focused workshops and laboratory training programs in pharmaceutical and biopharmaceutical sciences. She has played a key role in developing workforce training initiatives and mentoring engineering interns, preparing the next generation of professionals for advanced technical careers. From 2022 to 2024, Kristen served as Education & Training Coordinator for the Pharmaceutical Development Institute within the College of Pharmacy at The University of Rhode Island, where she created workforce development curricula for state and industry partners, and collaborated on strategic growth initiatives, grant writing, budgeting, and leadership communications.
Earlier in her career, Kristen held executive leadership roles in laboratory operations and chemical manufacturing. As Vice President and Laboratory Director at CEIMIC Corporation, she managed U.S. EPA and Department of Defense laboratory contracts, led a 20-person technical team, achieved top-tier national performance rankings, and implemented cost-saving and market expansion strategies, including business development initiatives in Brazil. Her foundation in engineering began at Clariant Corporation (formerly Hoechst Celanese), where she managed Process Safety Management programs under OSHA 1910.119, led compliance audits, supervised utilities operations, and managed multimillion-dollar energy budgets.
Kristen holds an MBA and a B.S. in Chemical Engineering, along with a B.A. in German through the International Engineering Program. She serves as Chair of the International Engineering Program Advisory Board at the University of Rhode Island and has authored multiple BioProcess Performance Reports® and technical presentations on hygienic components and service-life performance.
Throughout her career, Kristen has been recognized for her ability to integrate engineering rigor, regulatory insight, strategic growth, and educational leadership — helping organizations strengthen operations, ensure compliance, and advance innovation in the biopharmaceutical and process industries.