Sterility Assurance Scientist

Key Responsibilities:Participate in qualification and validation activities related to bioburden control strategies for facilities and equipment.Execute routine sterility assurance activitiesSupport media fill simulations and provide documentation to ensure compliance with regulatory guidelines.Analyze and interpret environmental monitoring data, identifying trends and potential risks to product quality.Collaborate with cross-functional teams to troubleshoot contamination events and recommend corrective actions.Maintain accurate records and ensure timely reporting of sterility assurance results.Qualifications:Experience in qualification or validation activities supporting contamination control measures in manufacturing facilities or equipment.Comprehensive understanding of aseptic techniques, either through hands-on operational experience or involvement in media fill processes.Prior experience participating in media fill simulations in a regulated environment.Ability to work in a fast-paced environment with strong attention to detail and organizational skills.Excellent written and verbal communication skills.Bachelor's degree in Microbiology, Biology, or a related field preferred, or equivalent work experience.Schedule: Night shift, 12-hour shifts on a rotation schedule. Must be flexible to accommodate additional work in extended hours and/or off-hour work.

Created: 2025-10-02