English English

Environmental Monitoring Technician

  Irwindale, CA,  United States |  Full time

Apply Now

Posting Date :  2022-04-20

Job Identification :  10975

Department  :  Quality Assurance

Role Summary: EM Technician will support production by performing room releases prior to batching and filling and environmental monitoring.

Key Responsibilities

  • Samples clean steam samples, RO water samples, pretreatment water samples, water for injection.
  • The position requires the individual to gown appropriately to the respective production rooms including aseptic gowning.
  • Perform environmental monitoring of the controlled production rooms, i.e., air sample monitoring, surface monitoring, non-viable particle counts.
  • Perform personnel monitoring of production operators using contact plates; this requires coordination with production personnel.
  • Reading plates if needed.
  • Perform environmental monitoring of aseptic filling operations (class 100).
  • Train personnel on aseptic gowning and aseptic behaviour.
  • Document work in master production records, logbooks, data sheets, as applicable.
  • Participate and write environmental notifications and deviation investigations, as applicable.
  • Prepare and revise standard operating procedures.
  • Ensure all work is carried out in compliance with Good Manufacturing Practices (cGMP) and company Safety policies.
  • Perform Line clearance and Line release for compounding and filling.
  • Train personnel for tasks mentioned above.
  • Any other duties as assigned.

Role Requirements:

  • Minimum of 2-3 years experience in Manufacturing environment, preferably in a pharmaceutical or food industry.
  • Familiar with cGMPs
  • Associate Degree in Science (Biology, Microbiology or related science)
  • Good aseptic techniques, documentation skills, computer skills and technical writing skills
  • Self directed individual
  • Must be able to build collaborative relationships with other departments including production, quality control and validation.
  • Good time management skills. Must be able to handle competing priorities.
  • Strong verbal and writing skills in English

glassdoor reviews