This position is responsible for the management, maintenance and repair of all building control systems, air filtration systems, equipment and utility systems ensuring compliance with federal regulations associated with the manufacturing of biologic agents at the Molecular and Cellular Therapeutics (MCT). The person in this role must have working knowledge of Good Manufacturing Practices as it applies to facility maintenance and operations and the impact that these requirements play upon facility management and day to day operations. This is a supervisory level position which includes supervising, coordinating daily activities and providing technical guidance to MCT Quality Engineering staff.
Oversight of facility operations and management of all equipment • Coordinates and performs equipment repairs, and preventative and calibration maintenance including HVAC and building control systems. Maintains records accordingly. • Maintain and respond to facility engineering monitoring systems to assure that appropriate and timely corrective actions are taken with respect to clean room environment and critical equipment controls. • Oversee the work of external vendors and University Facilities Management ensuring services provide comply with UMNl policies. • Create, revise and review standard operating operating procedures pertaining to building systems and equipment. • Ability to identify system and day to day problems and take a proactive to mitigate problems and determine corrective action. • Manage facility projects, develop timelines and hold staff accountable to deliverables and deadlines. • Direct the work of other employees including assign work, monitoring for completion of tasks, performance review, and discipline
Critical Skills • Able to perform calibration, maintenance and repairs of laboratory equipment including use of Calibration Software (CMS). • Knowledge of - Electrical, plumbing, HVAC, refrigerators, freezers, freezers, liquid nitrogen Systems, medical air compressor and general lab equipment • Ability to trouble shoot HVAC and building systems • Perform on & offsite building automation and data acquisition modifications as needed during off hours, weekends and holidays • Shared on call 24/7/365 via mobile phone and PC • Knowledge of clean room systems, common labs and environmental monitoring for such areas • Ability to use, Calibration Software (CMS) • Understand and interpret, mechanical, structural and architectural blue prints • Ability to design & fabricate customized items needed to support specialized equipment • Computer skills: proficient in Word and Excel and familiar with data entry into database systems.
Knowledge of the following Data Acquisition Components • Analog and Digital connections • Analog input calibration • Transmitter installation • Hardwired Jack installation • Software channel creation in system
All required qualifications must be documented on application materials.
Required Qualifications • BA/BS plus fours years of experience or a combination of related education and work experience to equal at least eight years.
Preferred Qualifications • Minimum of 5 years relevant technical experience in maintenance and repairs of laboratory equipment and building control systems (HVAC, utility etc..) used in product manufacturing setting. • Knowledge of or experience in Good Manufacturing Practices (cGMP) controlled manufacturing environment. Must be able to demonstrate knowledge of GMP principles as they would apply to biologic or pharmaceutical manufacturing.
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.