Sterility Assurance Scientist

JOB DESCRIPTIONOur pharmaceutical manufacturing client is seeking a Sterility Assurance Scientist (Night Shift) to support sterile/parenteral manufacturing operations. This individual will serve as a technical resource on the manufacturing floor, providing guidance on aseptic processing, contamination control, environmental monitoring, sterility assurance, and cleanroom best practices. The role partners closely with Operations, Quality, Environmental Monitoring, Engineering, and Technical Services teams to support manufacturing activities, investigations, CAPAs, process improvements, and sterility assurance programs. The majority of time will be spent in GMP manufacturing areas supporting production activities, troubleshooting issues, coaching operators, and ensuring compliance with aseptic processing standards.REQUIRED SKILLS AND EXPERIENCEBachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.5+ years of experience supporting pharmaceutical or biopharmaceutical manufacturing operations.Experience in sterile, aseptic, parenteral, or injectable product manufacturing environments.Strong understanding of contamination control, sterility assurance, environmental monitoring, and aseptic processing.Experience conducting manufacturing investigations, root cause analysis, deviations, and CAPA activities.Proven ability to provide hands-on technical support within GMP manufacturing environments.Experience partnering cross-functionally with Manufacturing, Quality, Engineering, and Operations teams.Ability to work within cleanroom environments and provide floor-based manufacturing support.NICE TO HAVE SKILLS AND EXPERIENCEExperience in TSMS, MSAT/MS&T, Sterility Assurance, Environmental Monitoring, or Technical Services functions.Background supporting aseptic filling, formulation, visual inspection, or sterile drug product manufacturing.Experience with smoke studies, airflow visualization, APS (aseptic process simulations), or EM programs.Familiarity with TrackWise, Veeva Vault, Kneat, Pharmasuite, MODA, PI Vision, or similar GMP systems.Experience training and mentoring operators or technicians on aseptic techniques.Prior support of 24/7 commercial pharmaceutical manufacturing operations.Experience analyzing environmental monitoring and microbiological data trends.