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
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.