Principal ScientistSME for Rapid Microbiology

Medvacon Life Sciences

Job Location:

East Windsor, NJ - USA

Hourly Salary: USD 80 - 90

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

The 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.

Key Responsibilities
1. Instrument Installation & Setup

Lead installation and commissioning of ScanRDI systems in collaboration with vendor
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 troubleshooting

2. Qualification (IQ/OQ/PQ)

Author and execute Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols
Define acceptance criteria aligned with intended use (sterility testing environmental monitoring etc.)
Coordinate calibration and preventive maintenance programs
Ensure traceability of qualification activities for audit/inspection readiness

3. Method Development

Design and optimize rapid sterility testing methods using ScanRDI including:
- Sample preparation and membrane filtration
- Staining optimization and reagent compatibility
- Interference and background fluorescence assessment
Evaluate product-specific impacts (e.g. preservatives turbidity autofluorescence)
Develop recovery strategies for low-level and stressed organisms

4. Method Validation

Lead validation studies in accordance with USP <1223>
Execute and document:
- Accuracy / equivalence to compendial methods
- Limit of detection (LOD)
- Specificity (organism panel)
- Precision and robustness
Develop statistical justifications and validation reports suitable for regulatory submission and inspection

Required Qualifications

PhD or MS in Microbiology Biology or related field (or equivalent experience)
8 years of experience in pharmaceutical microbiology or sterile manufacturing
Direct experience with rapid microbiological methods (ScanRDI strongly preferred)
Demonstrated experience in aseptic processing and sterility testing

Key Competencies

Deep technical expertise in microbiology and rapid detection technologies
Strong understanding of GMP and regulatory expectations
Ability to translate scientific data into regulatory-defensible conclusions
Excellent problem-solving and troubleshooting skills
Strong communication skills for cross-functional and regulatory interactions

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Required Experience:

Staff IC