Environmental Monitoring Technician I

4 weeks ago


Shirley, New York, United States American Regent, Inc. Full time

Nature and Scope

The Environmental Monitoring Team at American Regent, Inc. is responsible for ensuring the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs.

The team works in concert with and assists the manufacturing department, playing a critical role in maintaining environmental control of the aseptic manufacturing facility.

The Environmental Monitoring Technician I position is primarily responsible for performing environmental monitoring activities, including water collection, air, surface, and personnel monitoring within the sterile manufacturing facility.

Key Responsibilities

  • Conduct environmental monitoring activities, including air (Viable and Non-viable), surface, and personnel inside the sterile manufacturing areas.
  • Conduct water sampling throughout the facility.
  • Maintain accurate records of work performed in MODA and Laboratory systems according to Good Documentation Practices, SOPs, and policies.
  • Assist with data entry for analysis and trending.
  • Communicate any discrepancies or deviations to supervision/management upon discovery.

Requirements

  • Associate Degree in microbiology, biology, or a related scientific field preferred.
  • Academic or industry work experience in a laboratory setting or manufacturing with a focus on microbiology preferred.
  • Ability to work independently with minimal supervision.
  • Working knowledge of MS-Office software and PC skills required.
  • Ability to work in a fast-paced environment.
  • Ability to work in a team-oriented environment.

Physical Environment and Requirements

  • Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.


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