Technician IV - Microbiology

Role Summary

Technician IV - Microbiology performs microbiological and chemical testing of water used in the manufacturing process, raw materials, in-process samples, and final product in accordance with specifications. The role includes growth promotion, endotoxin, bio burden, TOC, pH and conductivity testing, as well as environmental monitoring and gowning sampling. It provides support in method transfer, equipment/instrument qualification and process validation, and adheres to cGMP, GLP, and safety rules.

Responsibilities

• Perform microbiological/chemical testing following procedures, methods and specifications within the required time frame.
• Provide support in validations, special sampling, and during planned or unplanned reinstatements.
• Document the test results to all final products, environmental monitoring (EM), water samples following procedures.
• Identify, collect and submit all LIMS required samples.
• Perform identification, growth promotion, and other general microbial testing requirements
• Perform the general cleaning/maintenance of laboratory equipment such as incubators, refrigerators as required per procedures
• Maintain the materials, reagents, and media inventory required in the MEC laboratory
• Comply with all training certifications as required by position requirements.

Qualifications

• Associate degree in Science (major in Biology, Chemistry, Microbiology or Medical Technology). Bachelor degree in Science (Microbiology) highly desirable.
• Minimum experience of two years in the laboratory, specifically in the environmental monitoring (facility and during process).
• Experience in the following testing/methodology is required: endotoxin by Kinetic method (turbid metric/ chromogenic), bio burden (membrane filtration). Experience required with the following equipment (RCS, Climet).