Sterile Compounding Environmental Monitoring Technician
Sterile Compounding 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 cleanrooms 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.
Primary Responsibilities
Environmental Monitoring & Sampling
- Perform viable and non‑viable EM in ISO 5, 7, and 8 areas, including:
- Active air sampling
- Passive air sampling (settle plates)
- Surface sampling (contact plates/swabs)
- Non‑viable particle counting
- 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
Microbiological Media Handling
- Prepare, label, transport, incubate, and track microbiological media plates.
- Document incubation start/stop times and environmental conditions.
- Perform plate reading, trending, and reporting.
Deviation, Investigation & CAPA Support
- 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.
Compliance & Documentation
- 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.
Equipment & Facility Support
- 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.
Cross‑Functional Collaboration
- 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.
Qualifications
- 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.
Knowledge, Skills, and Abilities
- 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.
Core Competencies
- 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
Physical and Environmental Requirements
- Ability to work in ISO‑classified cleanrooms with full gowning requirements.
- Ability to lift up to 25 pounds as needed.
- Ability to stand, walk, and perform sampling activities for extended periods.