Environmental Monitoring Technician

About the job

This role is for an Environmental Monitoring Technician that will perform testing work at Client sites, including air travel (10-20%).

Your Role:

The Environmental Monitoring Technician performs environmental monitoring and routine microbiological testing within a GMP biopharmaceutical manufacturing organization.
 

• Performs routine and non-routine Environmental Monitoring (EM) such as water sampling, non-viable particulates, viable air, viable surfaces, and gas testing in cleanroom environments within the Manufacturing area at Client’s site, as per applicable standard operating procedures (SOP).
• Perform environmental monitoring for aseptic filling processes according to SOP.
• Operate monitoring equipment that includes but is not limited to Laser Particle Counter, Viable Air Sampler, Microscope, and pH meter.
• Read EM (Environmental Monitoring) data and document results on relevant forms.
• Perform trending and generate trending charts for EM data.
• Participate in validation/verification of controlled environments such as cleanroom, and gowning qualification.
• Perform Quality Control testing such as media and organism qualification as per applicable procedures.
• Assist in USP standard testing including but not limited to water sampling, incubation of samples, and enumeration.
• In cooperation with the Laboratory Manager, responsible for the preventative maintenance of critical EM equipment.
• Monitor test status and conditions as described in Work Instructions and SOPs.
• Record test results accurately and legibly on all documents.
• Technical report writing including text, tables, graphs, and diagrams.
• Report any deviations and/or nonconformities to Management as well as provide possible preventive and corrective measures to prevent future deviations and non-conformities.
• Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues.
• Follow and perform process qualifications and validations for procedures and/or equipment.
• Update procedures for improvement to methods.
• Able to lift at least 50 lbs.
• Assist in the training of new EM Laboratory Technicians.
• Perform bioburden testing of samples per USP, EP requirements.
• Perform Area Release per protocol for campaigned manufacturing areas.
• Comply with all safety policies, practices, and procedures.
• Participate in proactive team efforts to achieve departmental and company goals.
• Driving won car for offsite work.
• Perform other duties as assigned.