Environmental Monitoring Technical Specialist

Job description

Join our QC Microbiology team where you’ll play a critical role in maintaining environmental monitoring excellence across our sterile manufacturing operations. This individual contributor position reports to the QC Microbiology Manager and offers the opportunity to impact product quality and patient safety through rigorous data analysis and regulatory compliance. As the Environmental Monitoring Technical Specialist, you will be responsible for performing comprehensive trending analysis of environmental monitoring data for routine surveillance programs and specialized projects such as EMPQs. You will collaborate with multifunctional teams, support deviation investigations, and ensure all work meets FDA, EMA, and Health Canada requirements while following industry best practices from USP, PDA, and ISPE. Essential Job Functions: Perform trending analysis of environmental monitoring data for viable and non-viable particulates from routine surveillance and EMPQ programs Author and maintain Environmental Monitoring Performance Qualification (EMPQ) protocols and reports in compliance with regulatory requirements Initiate and write Support QC microbiology and environmental monitoring labor...