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Facility Mechanic

Duties and Responsibilities:

Responsible for maintaining all facility and production equipment for 21 CFR 210/211/212 compliance, including AC system, utility system, ventilation system, cleanroom system, electric system, water supply system etc. Maintain and routinely test compliance of clean rooms, LAF hoods and shielded hot cells to ISO 14644 standards. Create and maintain records for facility and equipment validation, qualification, calibration, and maintenance. Write and develop documentation for validations, troubleshooting, maintenance, operation procedures, and qualifications. Operate equipment and train production staff on proper use and care. Coordinate with contractors to perform routine maintenance and qualifications of equipment. Troubleshoot, diagnose and repair equipment as necessary to maintain or improve operability in a timely manner. Maintain an adequate supply of replacement consumable and critical parts for equipment.

QUALIFICATIONS:

• Bachelor’s degree in mechanical engineering, chemical engineering, electric engineering, or related field preferred
• Knowledge of GMP/GLP principles preferred
• Knowledge of cleanroom (ISO 7) operations preferred
• Extensive knowledge of facility engineering system controls (e.g. AC systems, utility systems)
• Ability to maintain TEMA and CRP 6 dispensing unit preferred
• Ability to perform or coordinate equipment maintenance and repairs
• Ability to perform trouble-shooting for scientific equipment

 

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