We are hiring an Environment Monitoring Technician I. The Environment Monitoring Technician will be Performing tests for monitoring environmental conditions throughout the facility during sterile filling activities and maintain all documentation for traceability This person will be performing designated testing, monitoring, calibration, and maintenance of lab equipment in conjunction with approved procedures and test methodologies. This position will be for 2nd shift.
Provide documentation support of testing and monitoring activities in the QC lab.
Document environmental monitoring of the production rooms.
Monitor and report activities related to the on-line monitoring program.
Perform testing as designated and upon satisfactory training qualification.
Testing on environmental conditions to monitor regulated areas.
Maintain and record data clearly and precisely
Perform identification and related testing in conjunction with microbial contamination
Maintain an organism library while documenting and archiving new organisms found in clean rooms
Provide information regarding environmental monitoring excursions
High School diploma. Some college courses in Microbiology preferred. Degree in Microbiology ideal.
Knowledge of cGMP and GDP preferred. Cleanroom experience preferred.
Good lab safety
Basic understanding of 21CFR211 – cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material specifications, and related areas.
While performing the duties of this job, the employee is frequently required to read, compile, compute and record numerical and statistical data.
Duties require the employee to gown up for entering the cleanroom. Use of hand dexterity to manipulate fluids and powders to perform applicable tests in clean room environments, laminar flow hoods, and laboratory benches.
The employee is occasionally required to walk, sit, use hands to handle, feel or reach with hands and arms; climb or balance; and talk or hear.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.