About the role
Job Description
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
Qualifications
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
Additional Information
Position is full-time, Monday-Friday, generally 8 a.m. - 5 p.m., weekend work might be expected. Candidates currently living within a commutable distance of Rahway, NJ are encouraged to apply. Compensation is between $27-31/hr based on experience.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
* Life and disability insurance * 401(k) with company match * Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.