Environmental Monitoring Technician

5 days ago

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

The Environmental Monitoring Team at American Regent, Inc. plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The team works in concert with the manufacturing department to ensure the production of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs.

Key Responsibilities
  • Plan daily workload to meet requirements.
  • Conduct environmental monitoring activities, including air, surface, and personnel monitoring within the sterile manufacturing facility.
  • Collect and analyze water samples throughout the facility.
  • Perform sampling of compressed air, clean steam, and nitrogen.
  • 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 and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • High School Diploma or GED equivalent required.
  • Associate Degree in microbiology, biology, or related scientific field preferred.
  • Academic or industry work experience in a laboratory setting or manufacturing with a focus on microbiology preferred.
  • Knowledge of aseptic technique preferred.
  • Ability to work independently with minimal supervision.
  • Organization and attention to detail.
  • Excellent communication skills (oral and written).
  • Working knowledge of MS-Office software and PC skills required.
  • Good work ethic and highly motivated.
  • Ability to work in a fast-paced environment.
  • Ability to work in a team-oriented environment.
Physical Environment and Requirements

The employee must be physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE is essential for the health and safety of employees.

Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.

Employee must be able to occasionally lift and/or move up to 25 pounds.

Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites.

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