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Description
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
Duties and 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.
Qualifications
- 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.
- 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.
- Basic proficiency with Microsoft Office applications and electronic documentation systems preferred.
Working conditions
Fast pace, lab-oriented work environment. Evening and weekend work may be required.
Physical requirements
While performing the duties of this job, the employee may be required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift, and/or move up to 25 pounds.
No direct reports.
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.
Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.?