Responsibilities Primary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms. Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces) Builds credibility within the lab group by performing high quality work Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns Performs media fills and fillfinish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity Acts as Quality Control authority for aseptic flow and behavior within cleanrooms Utilizes MODA to enter, compile, and trend environmental data for reporting purposes Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility Effectively communicates results of own work through discussions and documentation with some input from supervisor Flexibility in following unique campaign requirements that may include off-hour and weekend work May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.