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.