Sterility Assurance Expert

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LI-OnsiteLocation:

Morris Plains, NJ, United StatesRelocation Support:

This role is based in Morris Plains, NJ, United States. Novartis is unable to offer relocation support: please only apply if accessible. This is an opportunity to play a critical role in protecting patients by shaping and defending sterility assurance strategies for advanced aseptic manufacturing. As the Sterility Assurance Expert, you will provide hands‑on technical leadership across aseptic processing, microbial control, environmental monitoring, and contamination investigations, ensuring every decision is scientifically sound, data‑driven, and inspection‑ready. Partnering closely with Operations, Quality, and Technical teams, you will serve as a trusted authority who drives risk‑based decisions, strengthens compliance with evolving regulatory expectations, and continuously improves sterility assurance programs in a highly regulated, mission‑critical environment. Key ResponsibilitiesServe as site sterility assurance expert for aseptic processing and microbial control programsDesign, maintain, and improve sterility assurance strategies aligned with global regulatory expectationsLead sterility‑related deviations, contamination investigations, and risk‑based decision makingOwn environmental and personnel monitoring strategies, including trending, escalation, and continuous improvementAuthor, review, and approve sterility assurance documentation, validations, and technical rationalesRepresent sterility assurance during regulatory inspections, audits, and quality governance forumsPartner cross‑functionally to resolve sterility risks and strengthen inspection readiness and complianceEssential RequirementsBachelor's degree in a scientific or technical field, preferably Microbiology or a related disciplineExtensive experience supporting sterility assurance programs in regulated biopharmaceutical manufacturing environmentsDeep understanding of aseptic processing, microbial control strategies, and contamination risk managementProven experience leading sterility‑related investigations, environmental monitoring programs, and corrective action planningStrong knowledge of global regulatory expectations, including United States and European health authority requirementsAbility to apply scientific judgment, analyze complex data, and communicate clear, compliant recommendationsDesirable RequirementsExperience supporting sterility assurance activities for aseptic cell or gene therapy manufacturingDirect participation in regulatory inspections with ownership of sterility assurance topics and responsesThe pay range for this position at commencement of employment is expected to be between $108,500 and $201,500 per year; however, while salary ranges are effective for a defined period, fluctuations in the job market may necessitate adjustments. Final pay determinations will depend on a variety of factors, including but not limited to geographic location, experience level, knowledge, skills, and abilities. The total compensation package may also include other elements, such as a performance‑based bonus and a full range of medical, financial, and other benefits, including retirement programs and paid time off. Details of participation in these benefit plans will be provided if an offer of employment is made. Employment with Novartis is at‑will, and the company reserves the right to modify compensation at any time based on individual, business, or market factors.

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