Environmental Monitoring (EM) Specialist

About the role

We are seeking a motivated and detail-oriented Environmental Monitoring (EM) Specialist to perform routine environmental sampling and support contamination control within our sterile pharmaceutical compounding cleanroom facilities.

Responsibilities

• Perform routine non-viable and viable air sampling, surface sampling, and personnel monitoring sampling within ISO-classified cleanroom environments.
• Ensure proper handling and labeling of sampling media to maintain integrity throughout the sampling and incubation process.
• Accurately document sampling events, locations, results, and observations in compliance with internal SOPs and regulatory expectations.
• Adhere to defined sampling schedules and respond to unscheduled or investigative sampling needs.
• Manage the proper incubation of solid and liquid microbiological media at appropriate temperature conditions (e.g., 20–25°C and 30–35°C).
• Perform interim and final readings of incubated media plates to identify and enumerate Colony Forming Units (CFUs).
• Report and investigate results at alert and/or action levels.
• Support the Microbiologist in responding to microbial growth events, including sample handling, documentation of excursions, and generation of preliminary reports.
• Cook up and submit microbial-positive samples to third-party laboratories and assist in investigation data gathering.
• Maintain investigation logs and contribute to root cause analysis and corrective action activities.

Requirements

• Minimum 1 year of experience in one or more of the following: Non-viable particulate air sampling, Viable air sampling using impaction or settling plates, Surface sampling using contact plates or swabs, Personnal aseptic technique and gown sampling.
• Knowledge in gram staining and microbial growth identification.
• Ability to work in sterile garb for extended periods within an ISO Class 5 or cleaner environment.
• Successful completion or ability to pass initial and ongoing garbing and aseptic competency evaluations.
• Working knowledge of USP , USP , USP , and sterile compounding requirements.

Preferred Qualifications

• Licensed Pharmacy Technician with active state licensure and PTCB certification.
• Prior experience in a 503A or 503B compounding pharmacy or aseptic pharmaceutical manufacturing environment.
• Familiarity with microbial growth morphology and plate reading.
• Understanding of incubation practices, environmental excursion documentation, and laboratory sample chain-of-custody procedures.
• Strong attention to detail and commitment to aseptic technique and contamination control.