Environmental Monitoring Technicians - I

Our Manufacturing & Supply Division is dedicated to being the most trusted global supplier of biopharmaceuticals. Within our Quality Operations group, we ensure that every component of our products meets the highest standards of safety, efficacy, and regulatory compliance. We are seeking an Environmental Monitoring (EM) Analyst to support the aseptic manufacturing operations by maintaining the environmental and utility monitoring program. This role is essential in ensuring product quality through rigorous environmental testing, data analysis, and compliance with Good Manufacturing Practices (GMP). The ideal candidate will have hands-on experience in microbiological or aseptic environments, strong attention to detail, and the ability to work effectively during non-traditional hours in a highly regulated manufacturing setting.

Responsibilities

• Perform environmental sampling of classified areas, including active air, surface, and non-viable air sampling.
• Collect and test qualified utility systems, including Clean Steam, Water for Injection (WFI), and compressed gases.
• Conduct routine personnel monitoring and compile accountability reports (weekly/monthly).
• Record, review, and approve data entries in LIMS and other documentation systems.
• Compile and evaluate environmental monitoring data to identify and report adverse trends.
• Author and summarize Requalification, Performance Qualification (PQ), and Special Study protocols.
• Support Performance Qualification activities for cleanroom and utility systems.
• Manage and calibrate environmental monitoring equipment; maintain document control and logbooks.
• Support investigations, TOC analysis, conductivity testing, and gas testing as required.
• Contribute to annual reviews, audits, and compliance-driven documentation.

Education

• Minimum: Associate’s degree (preferably in a scientific field).
• Preferred: Bachelor’s degree in Biological Sciences.

Experience

• Minimum 1 year of post-degree experience in Environmental Monitoring, Aseptic Manufacturing, or Microbiological Laboratory Operations.
• Strong oral and written communication skills; ability to clearly present findings and collaborate across teams.
• Demonstrated attention to detail, flexibility, and awareness of production and quality control issues.
• Working knowledge of GMPs and regulatory requirements in vaccine or sterile pharmaceutical environments.
• Ability to perform physical tasks such as sitting, standing, lifting up to 50 lbs, and repetitive hand/finger movements.

Preferred Skills:

• Hands-on EM sampling experience in a GMP pharmaceutical setting (not environmental/EPA).
• Experience with Quality Control, Quality Assurance, or cGMP operations.
• Prior experience using GLIMS or similar laboratory information management systems.

Additional Information

• Shift: Wednesday–Saturday, 4:00 PM – 2:30 AM EST (4x10 schedule).
• Training Period: 8–12 weeks (flexible hours; may include day or evening shifts Monday–Friday).
• Pre-employment Screenings: Varicella titer and BCG clearance required prior to start date.
• Work Environment: Must adhere to all Merck safety, gowning, and appearance policies (no jewelry, nail polish, long nails, makeup, or athletic attire).
• Note: Master’s or Ph.D. degrees are considered overqualified for this position.