Microbiologist (Environmental and Utilities Monitoring)

EurofinsRahway, NJ, United StatesonsiteSalary not postedView the original posting at Eurofins ↗

In this role, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a good manufacturing practices (GMP) microbiology laboratory, including finished products testing, utilities, and environmental monitoring. Primary Responsibilities Perform routine viable and non‑viable Environmental Monitoring of classified cleanroom areas (Grad A-D), including surfaces, air, and equipment. Conduct active air, passive air (settle plates), surface sampling, in accordance with site EM programs and GMP requirements. Operate and maintain EM instruments (e.g., viable air samplers, particle counters, RODAC plates, isolator/BSC environmental sampling tools). Execute aseptic sampling techniques to ensure data integrity and contamination‑free sample collection. Perform utility sampling/testing (WFI, purified water, clean steam) and support routine water system monitoring. Perform microbiology laboratory testing associated with EM samples, including bioburden, microbial identification, and endotoxin testing. Trend, analyze, and interpret EM data; escalate atypical or out‑of‑trend (OOT) results and support investigations. Participate in deviation investigations, root cause assessments, and CAPA development related to environmental or microbiological events. Maintain accurate documentation of sampling activities in compliance with ALCOA and data‑integrity principles. Inventory management. Conduct microbiology finished goods testing and biological indicator (BIs) testing Support of sterile operations within the quality control department including utilizing isolator for sterility testing, conduct method suitability testing, endotoxin, microbial enumeration, media / reagent quality control testing, Experience with testing in clean room environments preferred Conduct the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles Partner with internal stakeholders and partners, including Quality, Pipeline, and Operations. Perform second scientist review microbiology experiments in line with GMP expectations Support internal and external compliance audit activities. May need to be flexible with weekday work hours and weekend support as needed Minimum Requirements: Minimum 2 years of pharmaceutical industry experience for applicants with a MS degree or 3 years of experiences for BS degree in Microbiology or related Biological Sciences, or equivalent with direct microbiological testing GMP experience A proven record of microbiology laboratory experience. Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role. Knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and utilities testing in a GMP environment Knowledge of current microbiology industry guidelines and compendia Authorization to work in the United States indefinitely without restrictions Preferred Experience * Knowledge in sterile, nonsterile and aseptic manufacturing and associated GMP product testing * Experience in supporting quality investigations in the microbiology discipline * Experience with MODA, SAP, Veeva, LIMS is a plus

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