Sterility Assurance Scientist

Job Title: Sterility Assurance Scientist IIILocation: Princeton, NJ (Remote)Duration: 10 Months Job Summary:We are seeking an experienced Sterility Assurance Scientist III to support sterilization development and validation activities within a regulated environment. The ideal candidate will have strong expertise in ethylene oxide (EO) sterilization, including validation, residual testing, and cycle optimization, along with proven ownership of CAPA, Non-Conformances (NCs), and Deviations.This role requires a self-driven professional capable of independently leading sterilization-related quality and compliance initiatives.Key Responsibilities:Own and lead CAPA, Deviations, and Non-Conformances (NCs) including investigation, root cause analysis, implementation, and effectiveness checksDesign, develop, and execute EO sterilization validation protocols in compliance with ISO 11135Perform and review EO residual testing in accordance with ISO 10993-7Develop and optimize EO sterilization cycles to ensure product safety, efficacy, and regulatory complianceCollaborate with cross-functional teams (R&D, Quality, Manufacturing) to support sterilization strategiesAuthor and review validation documentation (IQ/OQ/PQ), protocols, reports, and technical justificationsEnsure compliance with cGMP, FDA, and international regulatory standardsSupport internal and external audits related to sterilization processesAnalyze data and trends to improve sterilization processes and ensure continuous improvementRequired Qualifications:Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field7+ years of experience in sterilization assurance or related fieldHands-on experience with:EO Sterilization Validation (ISO 11135)EO Residual Testing (ISO 10993-7)EO Sterilization Cycle Development & OptimizationProven experience owning CAPA, Deviations, and NCs (not just supporting)Strong knowledge of cGMP, FDA regulations, and quality systemsExcellent technical writing, documentation, and communication skills