Job Description

Job Summary:

We are seeking a detail-oriented and motivated Environmental Monitoring Lab Associate with experience in microbiological sampling and testing within the pharmaceutical industry. The ideal candidate will be responsible for supporting the environmental monitoring program by performing routine sampling, microbial testing, and data analysis to ensure compliance with cGMP, regulatory, and internal quality standards.

Key Responsibilities:

• Perform environmental monitoring (EM) in classified cleanroom areas including viable air, surface, and personnel monitoring.
• Conduct microbiological testing of environmental and utility samples (e.g., air, water, and surface samples) in accordance with SOPs.
• Perform microbial plate counting, incubation, and colony identification as required.
• Collect and process samples for routine monitoring, including cleanroom surfaces, compressed gases, and water systems.
• Assist in trend analysis of environmental data and support investigations of out-of-specification (OOS) or out-of-trend (OOT) results.
• Support routine calibration, cleaning, and maintenance of laboratory equipment.

Qualifications:

• Bachelor’s degree in Biology, Microbiology, or a related scientific discipline.
• 1–3 years of hands-on experience in environmental monitoring or microbiology lab testing within the pharmaceutical, biotechnology, or regulated industry.
• Familiarity with GMP, GLP, USP, and FDA guidelines related to microbiological testing and cleanroom operations.
• Proficient in microbial plate counting and aseptic techniques.
• Strong documentation and data entry skills; familiarity with LIMS or electronic lab notebooks is a plus.
• Experience in root cause analysis and deviation investigations.

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