WorkLlama, Inc.
Environmental Monitoring Technicians
WorkLlama, Inc., Durham, North Carolina, United States, 27703
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
Education
Associate’s degree in a science-related field (required)
Bachelor’s degree in Biological Sciences (preferred)
Experience
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
Preferred Experience
Environmental Monitoring sampling in a GMP pharmaceutical setting (non-EPA)
Quality Control, Quality Assurance, and/or cGMP experience
Experience using GLIMS, LIMS, SAP, TrackWise, or similar systems
Additional Information
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)
Pre-Employment Requirements
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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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
Education
Associate’s degree in a science-related field (required)
Bachelor’s degree in Biological Sciences (preferred)
Experience
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
Preferred Experience
Environmental Monitoring sampling in a GMP pharmaceutical setting (non-EPA)
Quality Control, Quality Assurance, and/or cGMP experience
Experience using GLIMS, LIMS, SAP, TrackWise, or similar systems
Additional Information
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)
Pre-Employment Requirements
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
#J-18808-Ljbffr