Owner and President
Mr. Asuncion is an Owner at TVS and serves as the company President, and he also is a Project Director and Process and Quality Affairs Consultant for TVS clients. With over 25 years of engineering, commissioning, qualification, validation, compliance, and quality experience in the pharmaceutical and biotechnology industries, including management roles in validation and quality assurance for commercial manufacturing operations, he is an essential asset for all TVS projects.
His background includes strong technical expertise in a wide array of systems, including sanitary and non-sanitary utility systems, facility architecture, HVAC systems, manufacturing equipment and processes (cell banking, cell culture, purification, liquid and powder fill/finish, product storage and transport), cleaning, sterilization, analytical instruments, process control systems, enterprise-wide software platforms, and data integrity. Mr. Asuncion’s technical knowledge also includes manufacturing, quality, and compliance operations (materials management, multi-product clinical and commercial manufacturing, engineering, CQV, maintenance and calibration, process validation, change control, document control, deviation investigation/resolution, lot release, auditing, and audit/inspection management).
Mr. Asuncion holds a B.S. degree in Mechanical Engineering from the University of California, Berkeley, and he is currently the President for the San Francisco Bay Area Chapter of ISPE and is an active member of the West Coast Chapter of PDA.