Environmental Monitoring Technician

Overview

The Sterile Compounding Environmental Monitoring Technician supports the Quality Unit by executing routine and non‑routine environmental monitoring (EM) activities within ISO‑classified clean rooms used for large‑scale sterile drug manufacturing. This position operates under FDA 21 CFR Parts 210/211, cGMP requirements, and USP 797/800 expectations. The technician ensures that environmental conditions consistently meet state, federal, and internal quality standards to protect product sterility and patient safety.

• Perform viable and non‑viable EM in ISO 5, 7, and 8 areas, including:
• Surface sampling (contact plates/swabs)
• Differential pressure, temperature, and humidity monitoring
• Execute EM according to approved SOPs, batch records, and validated methods.
• Assist with other duties and responsibilities assigned by management

• Prepare, label, transport, incubate, and track microbiological media plates.
• Document incubation start/stop times and environmental conditions.
• Perform plate reading, trending, and reporting.
• Document EM excursions and out‑of‑specification (OOS) results.
• Assist QA/QC with root‑cause analysis, impact assessments, and CAPA development.
• Support environmental investigations related to sterility failures or aseptic process deviations.

• Maintain accurate, contemporaneous records following Good Documentation Practices (GDP).
• Ensure all EM activities comply with:
• FDA cGMP (21 CFR 210/211)
• USP 797/800
• Facility SOPs and quality standards
• Participate in internal and external audits, including FDA inspections.

• Operate, clean, and maintain EM equipment (particle counters, air samplers, etc.).
• Report equipment malfunctions and support calibration/qualification activities.
• Assist with cleanroom certification activities and facility walkthroughs.

• Work closely with QA, QC Microbiology, QC Analytical, Production, and Facilities teams.
• Support aseptic behavior monitoring and training initiatives.
• Communicate EM trends, risks, and observations to the Quality Unit.

• High school diploma required, associate or bachelor’s degree in microbiology, biology, chemistry, or related field preferred.
• Experience in a 503B outsourcing facility, pharmaceutical manufacturing, or cGMP environment strongly preferred.
• Knowledge of aseptic processing, contamination control, and cleanroom behavior.
• Ability to follow strict SOPs and gowning procedures for ISO‑classified areas.
• Strong attention to detail, documentation accuracy, and situational awareness.
• Ability to stand for extended periods and work in full aseptic gowning.

• Working knowledge of aseptic processing, contamination control, and cleanroom operations.
• Familiarity with FDA cGMP regulations, USP 797/800, and environmental monitoring principles.
• Strong attention to detail and ability to follow strict procedural requirements.
• Effective communication skills and the ability to work collaboratively in a regulated environment.
• Ability to stand for extended periods and perform tasks requiring repetitive motion and full aseptic gowning.

• cGMP compliance mindset
• Strong observational and analytical skills
• Precision in sampling and documentation
• Effective communication across Quality and Production teams
• Ability to work in a regulated, fast‑paced manufacturing environment

• Ability to work in ISO‑classified clean rooms with full gowning requirements.
• Ability to lift up to 25 pounds as needed.
• Ability to stand, walk, and perform sampling activities for extended periods.