POSITION TITLE: Environmental Monitoring Technician
REPORT TO: Microbiology Supervisor
Under general supervision, perform various microbiological related activities for a cGMP compliant Fill/Finish operation. Ability to apply standard practices, techniques, procedures and criteria, is necessary. Must be able to summarize findings and prepare or assist in the preparation of reports, documents, records, etc., for assigned tasks.
- Ability to set-up, maintain and perform various environmental monitoring related activities as required for a cGMP compliant Fill/Finish operation according to the applicable guidelines, i.e. FDA, GMP, ICH etc.
- Ability to follow proper gowning practices for cleanroom environments.
- Ability to follow procedures to collect and process environmental monitoring samples in a controlled manufacturing aseptic and non-aseptic cleanroom environment.
- Perform environmental monitoring for aseptic filling processes.
- Perform personnel monitoring for aseptic gown qualification.
- Perform cleanroom air flow velocity testing.
- Ability to read viable EM plates and clearly document results on relevant forms.
- Ability to perform aseptic and relevant microbiological techniques such as microbial isolation, streak plate, Gram stain, and bioburden testing.
- Verify collection of manufacturing equipment rinse water.
- Prepare media and/or agents for testing and manufacturing purposes.
- Ability to operate EM equipment such as Climet Laser Particle Counter, Air IDEAL Sampler and Airdata Multimeter airflow velocity meter and verify that the equipment is within calibration prior to use.
- Carry out preventative maintenance of laboratory and testing equipment.
- Notify management of EM retest and any excursions or counts that exceeds the defined alert/action limits and assist in EM investigations.
- Maintain laboratory and manufacturing quality control.
- Performs assigned sampling tasks carefully according to standard operating procedure and supervisor instruction as per the daily environmental monitoring schedule.
- Ensures all work performed strictly adheres to cGMP.
- Ability to work independently as well as in a team atmosphere and work flexible hours to support manufacturing operations.
- Provide technical and administrative support for all activities to environmental monitoring, documentation, and quality auditing.
- Perform other related duties and responsibilities as assigned.
- Bachelor’s Degree with course work in Microbiology or related sciences preferred.
- Microbiology background and experience preferred.
- EM experience is a plus.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .