• Responsible for the preventive maintenance, calibration, and out of tolerance reports for all Manufacturing, Quality Control and Research Departments process equipment.• Monitor and respond to day to day environmental conditions of manufacturing equipment via Rees Environmental Monitoring system.• Member of Validation Team responsible for coordinating and executing IQ/OQ/PQ’s for all new equipment.• Responsible for vendor calibration and repairs to equipment.• Liaison with Domino’s Farms facility personnel regarding any building maintenance, security, and utility activities.

• Created and executed Software Validation OQ/PQ for TCM II Cooling and Heating System.• Revised Assembly and testing procedure for Sarns Delphin Centrifugal Module for use in execution of PQ.• Member of Validation Team responsible for coordinating and executing IQ/OQ/PQ’s, and PFMEA’s. Implemented Calibration and Preventative Maintenance procedures for lab equipment during the relocation of CDI Production Chemistry Lab from Tustin, CA to Ann Arbor, MI.

• Responsible for the preparation and execution of cleaning validation protocols and validation reports for packaging, solid and liquid process equipment.• Planned and coordinated cleaning validation activities to meet manufacturing time lines.• Monitored and responded to day to day environmental conditions of manufacturing suites via SCADA system.• Liaised between Clinical Manufacturing and Global Operations for maintenance and calibration activities.• Maintained documentation for preventive maintenance, calibration, and out of tolerance reports for process equipment.• Member of Hazardous Materials Response Team