Basic Functions:
Following set procedures and specifications performs a variety of microbiological, environmental and critical systems tests.
Laboratory equipment maintenance and trouble shooting.
Laboratory materials preparation, sterilizations and material receiving.
Review or approve laboratory documentation.
Task & Responsibilities:
Task & Responsibilities:
1. Following specifications and procedures, performs microbiological, environmental and critical system tests.
2. Participate and support Environmental, Safety and Health to meet organizational goals.
3. Verifies Incubator and refrigerators temperatures, assures they are within parameters.
4. Document all test performed.
5. Prepares media for environmental, sterility and growth tests areas.
6. Prepare materials for sterilization, sterilize materials when requested.
7. Sanitize areas per applicable procedures.
8. Monitor the Distilled water and Non-Distilled Water System.
9. Perform Bioburden testing to Plant components and Bags.
10. Perform microbiological monitoring in the surfaces and room air of the controlled rooms
11. Perform plant flora microorganisms Identification.
12. Be a Backup of other Laboratory Technicians and of the Environmental and LAL Microbiologist.
13. Maintain Micro data in a computerized system.
14. Notify the appropriate personnel about any finding/result out of limits.
15. Keep microorganism flora for Lab testing’s.
16. Evaluate Laboratory culture media growth promotion.
a. Execute validation or re-validation of lab equipment and test methods.
17. Other duties required for the position.
LABORATORY TECHNICIAN – ENVIRONMENTAL CONTROL
· Monitor the Plant HEPA filters and keep HEPA filters maps update.
· Verify Room Air Changes, pressure differential and Airborne particle to all controlled areas.
· Monitor production modules and LFH (Particle counts, airflow velocity, air flow patterns).
· Solution particle analysis to Maricao,and Stability studies product.
· Device particle analysis to San German and Haina when requested.
· Compressed air particle count test for all compressed air sample sites.
· Dew point and Johnson Oil indicator test.
LABORATORY TECHNICIAN – STERILITY AREA
· Sterility testing to batches manufactured that require sterility test.
· Sterilization studies sterility test
· Perform lab vessel qualifications studies
· Coordinate Lab. Purchase orders
· Materials receiving
· Micro Lab area materials requisition
LABORATORY TECHNICIAN – ENVIRONMENTAL CONTROL
· Monitor the Plant HEPA filters and keep HEPA filters maps update.
· Verify Room Air Changes, pressure differential and Airborne particle to all controlled areas.
· Monitor production modules and LFH (Particle counts, airflow velocity, air flow patterns).
· Solution particle analysis to Maricao,and Stability studies product.
· Device particle analysis to San German and Haina when requested.
· Compressed air particle count test for all compressed air sample sites.
· Dew point and Johnson Oil indicator test.
LABORATORY TECHNICIAN – STERILITY AREA
· Sterility testing to batches manufactured that require sterility test.
· Sterilization studies sterility test
· Perform lab vessel qualifications studies
· Coordinate Lab. Purchase orders
· Materials receiving
· Micro Lab area materials requisition
Education Required:
B.S. in Science (Microbiology, biotechnology, biology).
Experience:
Three years (3) experience as a Lab. Technician.
Application Question(s):
- Willing to Work in Maricao
Education:
Experience:
- Laboratory Technician: 3 years (Required)
Language:
Work Location: In person
