Omar Cruz Contec, Inc.

Omar Cruz is an industrial microbiologist with 30 years of extensive technical experience in contamination control within the biotech, pharmaceutical, OSD, and medical devices industries. He has held leadership roles at J&J and BMS. He specializes in contamination control, disinfectant validation, pharmaceutical microbiology, and aseptic processing, with a strong record of leading microbiological remediation efforts and regulatory compliance programs. Currently, at Contec Inc., he provides technical advice and training on contamination control for LATAM & United States. Omar has executed and mentored numerous DET studies for various pharmaceutical companies, evaluating over 20 disinfectant solutions using the USP <1072> approach. His expertise includes managing cGMP disinfection programs and developing disinfectant lifecycle programs. He has designed, optimized, and managed several environmental monitoring programs, as well as conducted microbiological out-of-specification investigations, including media fills and sterility test failures. Additionally, Omar is responsible for qualifying microbiological methods related to life sciences applications. He is an active member of the PDA, serving as President-Elect of the PDA Puerto Rico Chapter and the task force review committees for TR#3 and PDA TR#70. Omar actively contributes to industry standards and technical publications and is known for translating complex microbiological concepts into practical solutions for manufacturing environments.