Microbiology Technician Ii
hace 2 semanas
_MAIN PURPOSE OF ROLE_
The primary function of this position is to perform daily duties of the microbiology laboratory and tests and processes required to monitor the production area environment.
The individual will be responsible for carrying out assigned tasks, which could include laboratory experiments and testing of raw material and processes as per routine documented procedures and to perform the tasks for maintenance of the microbiology laboratory.
_ MAIN RESPONSIBILITIES_
Support the Microbiology Laboratory
- General laboratory cleaning (dishwashing, cleaning surfaces, etc.)
- Equipment preparation and sterilization/depyrogenation.
- Material Preparation ( Packaging and sterilization )
- Preparation of specialty test samples.
- Preparation of media and Fluids as required.
- Waste disposal as required.
- Perform Test Procedures and Environmental Monitoring
- Perform sterility testing of devices and components.
- Perform bioburden estimation of devices, components, and solutions.
- Perform Endotoxin Testing of devices, components and solution.
- Perform testing for Validations of product sterilization cycles.
- Perform the predetermined sampling and testing schedule to ensure that the controlled environment rooms and water systems meet the environmental specifications requirements.
- Ensures that raw materials and finished product requiring testing are sampled and tested.
- Record Equipment Monitoring System.
- Perform and document the Test results (media liquid and media plates) Validation and Calibration
- Maintains all required laboratory instruments and equipment validated.
- Maintains all laboratory instruments requiring calibration, calibrated.
- Assists in the validation of the manufacturing sterilizers, the CAE room and supporting. systems and the water systems.
_ Documentation _
- Accurate record keeping of lab procedures performed and their results.
- Maintain and file all laboratory test data and reports.
- Evaluates and maintains trend charts of environmental test data, water system, product tests and other microbiology related data.
- Maintains traceability of clinical product used for testing.
- Training (If Certified)
- Provides training to plant personnel regarding environmental, hygiene, product sampling and others as requested.
- Train other technicians in laboratory testing when required.
- Level of Review / Authority
- Test results are reviewed by Microbiologist/Supervisor.
_ Education_
High School Degree required.
_ Experience/Background _
0-2 years in similar roles
Shift TB
_ Experience Details _
Must have knowledge of basic laboratory equipment (such as pH meter, analytical balance, incubator, autoclave, etc)
_ Language Proficiency _
Basis English level
_ Preferred Qualifications & Education _
- Laboratory assistant diploma or studies in microbiology, biology or biotechnology fields is a plus.
- Medical Devices Laboratory Training.
- Prior medical device experience
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