Rapid Microbiology -ScanRDI SME (IQ/OQ/PQ) - Must be US Citizen or GC

Location – Windsor Center Drive. East Windsor, NJ (100% onsite)Duration – 4 month contractThe Principal Scientist / SME for Rapid Microbiology is responsible for the end-to-end implementation of the ScanRDI for rapid sterility testing. This role leads instrument installation, setup, qualification (IQ/OQ/PQ), method development, validation, and lifecycle management in a regulated environment. The SME serves as the technical authority for rapid microbiological methods and ensures compliance with global regulatory expectations, including guidance from the FDA and pharmacopeial requirements such as USP <71> Sterility Tests and USP <1223> Validation of Alternative Microbiological Methods. Required Qualifications PhD or MS in Microbiology, Biology, or related field (or equivalent experience)8+ years of experience in pharmaceutical microbiology or sterile manufacturingDirect experience with rapid microbiological methods (ScanRDI strongly preferred)Demonstrated experience in aseptic processing and sterility testingDeep technical expertise in microbiology and rapid detection technologiesStrong understanding of GMP and regulatory expectationsAbility to translate scientific data into regulatory-defensible conclusionsExcellent problem-solving and troubleshooting skillsStrong communication skills for cross-functional and regulatory interactionsKey Responsibilities 1. Instrument Installation & Setup Lead installation and commissioning of ScanRDI systems in collaboration with vendor (e.g., bioMérieux)Ensure proper integration with laboratory infrastructure (LIMS, data systems, barcode systems)Establish instrument configuration, user access, and data integrity controls (ALCOA+ principles)Develop and approve system SOPs for operation, maintenance, and troubleshooting2. Qualification (IQ/OQ/PQ) Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocolsDefine acceptance criteria aligned with intended use (sterility testing, environmental monitoring, etc.)Coordinate calibration and preventive maintenance programsEnsure traceability of qualification activities for audit/inspection readiness3. Method Development Design and optimize rapid sterility testing methods using ScanRDI, including: Sample preparation and membrane filtrationStaining optimization and reagent compatibilityInterference and background fluorescence assessmentEvaluate product-specific impacts (e.g., preservatives, turbidity, autofluorescence)Develop recovery strategies for low-level and stressed organisms4. Method Validation Lead validation studies in accordance with USP <1223>Execute and document: Accuracy / equivalence to compendial methodsLimit of detection (LOD)Specificity (organism panel)Precision and robustnessDevelop statistical justifications and validation reports suitable for regulatory submission and inspection