Microbiologist (Environmental and Utilities Monitoring)

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.