Jeff Felgar

Support new product development teams from a sterility assurance and contamination control perspective to ensure the project timelines and regulatory requirements are met. Provide SME support in the areas of sterilization, device processing, and contamination control.

Managed Microbiology and Environmental Monitoring laboratories and staff responsible for product bioburden and sterility testing, microbial identifications, equipment and sterilization validations, water testing, viable and non-viable particulate sampling, compressed air monitoring, LIMS implementation and administration, reusable device cleaning steam sterilization validations, and water system, compressed air system and cleanroom validations. Performed validation, requalification, and routine monitoring of aseptic filling operations.

Supported all global Zimmer sites in the design and cleaning validations of reusable devices.

Managed the Environmental Services laboratory responsible for monitoring over 50, ISO Class 7 cleanrooms and over 80, ISO Class 6 environments on all three shifts. The lab also monitored compressed air, purified water systems, and aseptic fill operations.