Microbiologist Position Available In Suffolk, New York

Microbiologist Long Island Labs, LLC Hauppauge, NY 11788 1. Environmental Monitoring (EM) Perform viable (air, surface, personnel) and non-viable particulate monitoring in cleanrooms (ISO 5/6/7/8). Track trends in microbial counts and investigate deviations. Ensure compliance with

GMP, USP

, and EU Annex 1 requirements. 2. Microbial Testing of Raw Materials, Water, and Finished Products Conduct sterility testing (USP , Ph. Eur. 2.6.1). Perform bacterial endotoxin testing (BET) using LAL (Limulus Amebocyte Lysate) methods (USP , Ph. Eur. 2.6.14). Test for bioburden (USP , Ph. Eur. 2.6.12) in raw materials, APIs, and finished products. Monitor water systems (Purified Water/WFI) for microbial limits (USP ). 3. Growth Promotion & Media Qualification Ensure sterility and growth promotion capability of culture media (USP , Ph. Eur. 2.6.12). Perform media fill trials for aseptic process simulations. 4. Microbial Identification Isolate and identify contaminants using biochemical, molecular (16S rRNA sequencing), or

MALDI-TOF

techniques. Investigate out-of-specification (OOS) results and root causes. 5. Method Validation & Verification Validate microbiological test methods per USP , Ph. Eur. 5.1.6, and ICH Q2 . Ensure compendial compliance for microbial limits, sterility, and endotoxin testing. 6. Compliance & Documentation Follow Good Documentation Practices (GDP) and maintain accurate records. Review and update SOPs related to microbiological testing. Support regulatory audits (FDA, EMA, WHO) and address observations. 7. Investigations & CAPA Lead microbial deviation investigations in production or environmental monitoring. Implement Corrective and Preventive Actions (CAPA) for contamination control. 8. Equipment & Lab Maintenance Maintain and calibrate lab equipment (autoclaves, incubators, laminar flow hoods). Ensure proper disinfection and aseptic techniques are followed. 9. Training & Safety Train lab personnel in microbiological techniques and GMP compliance . Follow biosafety protocols for handling microbial cultures.

Job Type:

Full-time Pay:

$60,000.00 – $90,000.00 per year

Benefits:

401(k) Health insurance Paid time off

Schedule:

8 hour shift

Work Location:

In person