Sterility Assurance Scientist

Job Description

Our 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.

Skills and Requirements

-Bachelor'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. -Experience 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.