Environmental Monitoring Technician

VIVEX BIOLOGICS INCMiami, FL
Onsite

About The Position

The Environmental Monitoring (EM) Technician is responsible for performing routine viable and nonviable environmental monitoring activities within controlled and classified environments. The technician collects environmental monitoring samples, performs personnel monitoring, maintains monitoring equipment, documents results, and supports contamination control activities to ensure compliance with regulatory requirements and internal procedures. This role contributes to maintaining the state of control of cleanrooms and controlled processing environments used for aseptic manufacturing, tissue processing, and other regulated operations.

Requirements

  • Ability to follow written procedures, maintain accurate records, and document activities in accordance with Good Documentation Practices (GDP).
  • Strong attention to detail with the ability to work independently and as part of a team in a fast-paced, regulated environment.
  • Effective verbal and written communication skills, including the ability to promptly escalate abnormalities, deviations, or environmental monitoring concerns to management.

Nice To Haves

  • Bachelor’s degree in biology, Microbiology, Environmental Science, or a related scientific discipline preferred; equivalent combination of education, training, and relevant experience may be considered.
  • Entry-level to two (0–2) years of experience in a regulated environment, such as biologics, medical device, pharmaceutical, tissue banking, laboratory, or cleanroom operations.
  • Basic understanding of environmental monitoring, aseptic technique, cleanroom behavior, gowning practices, or microbiological sampling preferred.
  • Basic proficiency with Microsoft Office applications and electronic documentation systems preferred.

Responsibilities

  • Perform routine viable and nonviable environmental monitoring, including active air, passive air, surface, personnel, and particle monitoring, in accordance with approved procedures and schedules.
  • Transport samples to the laboratory while maintaining sample integrity and chain of custody.
  • Ensure all monitoring activities are performed aseptically and in accordance with gowning requirements.
  • Perform environmental monitoring during routine operations, validation studies, and investigations as required.
  • Accurately document environmental monitoring activities in forms, logbooks, and electronic systems.
  • Review completed records for accuracy, completeness, and compliance with established procedures.
  • Report environmental monitoring excursions, abnormalities, and procedural deviations to management.
  • Operate environmental monitoring equipment, including air samplers, particle counters, incubators, and related instrumentation, and perform routine cleaning, maintenance, operational checks, and calibration status verification prior to use.
  • Assist with investigations involving environmental monitoring excursions and contamination events.
  • Participate in root cause investigations by collecting supporting information and documentation.
  • Support implementation of corrective and preventive actions (CAPAs) as assigned.
  • Maintain qualification and training requirements for environmental monitoring activities.
  • Participate in aseptic technique and cleanroom behavior training programs.
  • Support departmental continuous improvement initiatives.
  • Perform other duties related to environmental monitoring, laboratory support, or quality operations as assigned by management.
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