Pipette and Certification TechnicianWork with Purpose

Perform the calibration of laboratory pipettes and oversee pipette maintenance to ensure production standards are continuously met. Perform certifications of test containment equipment and associated components i.e. biological safety cabinets, isolators, fume hoods, and ISO classified cleanrooms in a cGMP environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Follow pre-set schedule to calibrate laboratory pipettes to ensure calibration standards and guidelines are met.
• Enter data in validated computer systems and provide documentation in compliance with cGMPs
• Coordinate upcoming calibrations with Operational departments and communicate required maintenance. Maintain pipette log in compliance with cGMPs
• Provide various services regarding certification, smoke studies, maintenance, and repair of biological safety cabinets, and perform a variety of tests to verify the protective effectiveness of cabinets in accordance with applicable standards.
• Knowledge of relevant industry standards (FDA, ISO 8655, ISO 14644-1, USP 800, USP 797 and IEST-RP-CC-006)
• Verify biological safety cabinet HEPA filter integrity and measure air velocity, differential pressures, airborne particulate, visualization of airflow and directional airflow in the working environment and inside the cabinets.
• Ability to perform ambient, florescent, ultra-violet light tests and noise level tests.
• Make recommendations for preventative maintenance, replacement parts, and repairs.
• Follow Standard Operating Procedures for calibrations, certification methods, and all areas of responsibility. Responsible for documentation as required by company policy, cGMP, and FDA
• Complete all work orders associated with the Preventative Maintenance (PM) program according to schedule and document maintenance in appropriate locations
• Match all work orders to calibration/ certification sheets and verify work orders for accuracy.
• Work in a cleanroom environment following standard operating procedures and training guidelines
• Maintain up to date records of required cGMP internal trainings and knowledgeable of any external changes to NSF and ISO requirements regarding Biological Safety Cabinets and Clean Rooms
• Perform off-hours alarm response when designated.

•    Perform all other related duties as assigned.

• Education: Trade school graduate or equivalent
• Experience: Two to four years of experience in laboratory, mechanical, electrical, or electronic field
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
• Knowledge of safety cabinet functionality
• In depth knowledge of hood and cabinet testing standards and test instrumentation is required
• Experience performing various field tests to verify air flows, HEPA filter integrity, containment of contaminated cabinet air, and test for other cabinet operational features.
• Ability to identify faulty safety cabinet conditions and make appropriate repairs.
• Knowledge of NSF and ISO requirements
• Certification/Licensure: None

•    Other: Able to organize workload effectively, accomplish tasks in a timely fashion and work independently. Strong computer skills for data entry