Environmental Monitoring Technicians
Job in
Durham, Durham County, North Carolina, 27703, USA
Listed on 2026-01-01
Listing for:
WorkLlama, Inc.
Full Time
position Listed on 2026-01-01
Job specializations:
-
Healthcare
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
We are seeking a detail-oriented Environmental Monitoring (EM) Analyst to support our Manufacturing & Supply Division in delivering high-quality biopharmaceutical products to patients worldwide. This role sits within Quality Operations and plays a critical part in maintaining compliance, ensuring product safety, and supporting a reliable global manufacturing network. The EM Analyst will execute environmental and utility monitoring activities in a GMP-regulated environment and partner closely with manufacturing and quality teams to uphold rigorous regulatory standards.
Responsibilities- Maintain and execute the Environmental Monitoring (EM) program in accordance with GMP requirements
- Perform environmental sampling in classified areas, including active air, surface, and non-viable air sampling
- Collect and test qualified utility systems such as Clean Steam, WFI, and compressed gases
- Perform routine personnel monitoring and sample accountability activities (weekly and monthly)
- Read EM plates and conduct TOC, conductivity, and gas testing
- Enter, review, and approve data within LIMS and other quality systems
- Compile, trend, and evaluate environmental data to identify adverse trends
- Support Performance Qualification (PQ) and re-qualification activities
- Author and summarize protocols, special studies, and annual reviews
- Support investigations and equipment calibration, documentation control, and other duties as assigned by management
- Associate’s degree in a science-related field (required)
- Bachelor’s degree in Biological Sciences (preferred)
- Minimum of 1 year post-degree experience in Environmental Monitoring, Aseptic Manufacturing, or Microbiological Laboratory Operations
- Basic understanding of GMPs and regulatory requirements for sterile pharmaceutical or vaccine manufacturing
- Strong attention to detail, flexibility, and awareness of production and quality control challenges
- Demonstrated oral and written communication skills
- Ability to sit, stand, and move within the workspace for extended periods
- Ability to perform repetitive tasks and lift up to 50 pounds
- Environmental Monitoring sampling in a GMP pharmaceutical setting (non-EPA)
- Quality Control, Quality Assurance, and/or cGMP experience
- Experience using GLIMS, LIMS, SAP, Track Wise, or similar systems
- Shift: Wednesday–Saturday, 4:00 PM–2:30 AM EST (4 × 10-hour shifts)
- Training Period:
- Duration: 8–12 weeks
- Schedule may vary (day shift 8:00 AM–5:00 PM EST or evening shift 4:00 PM–10:00 PM EST, Monday–Friday)
- Varicella titer and BCG screening required prior to start date
- Dress Code & Workplace Requirements:
- Business casual attire required
- No athletic/workout clothing
- No makeup, eyelash extensions, jewelry, long nails, or nail polish
- Adherence to Merck safety guidelines and time-off request policies is mandatory
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