Microbiologist

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.
• Execute 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.
• Support 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.

Qualifications

• 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, Mon-Fri 8am-5pm. Candidates currently living within a commutable distance of Rahway, NJ are encouraged to apply. Compensation is between $27-34/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.