Laboratory Technician IV - Microbiology

Role Summary

Perform microbiological and chemical testing for water, raw materials, in-process samples, and final product according to specifications. Conduct environmental monitoring and gowning sampling, support method transfer, equipment/instrument qualification, and process validation. Adhere to Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) to ensure safety and quality throughout manufacturing processes.

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 (2) 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).