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. This role is essential in ensuring a controlled environment for aseptic operations and maintaining compliance with USP <797>, USP <800>, and 503A/503B regulatory standards.

Working under the supervision of the Microbiologist, the EM Specialist will be responsible for executing all aspects of the environmental monitoring program, including sample collection, incubation, documentation, reporting, and assisting in microbial investigations and laboratory submissions.

This position will support our overnight shift.

You Will

• 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.
• Coordinate submission of 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.

You Have

• 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
• Personnel 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 <795>, USP <797>, USP <800>, 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.

Benefits

Our Benefits (There Are More but Here Are Some Highlights):

• Competitive salary & equity compensation for full-time roles

Conditions of Employment

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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