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SUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials.
SUMMARY: The Equipment Calibration and Maintenance Technician position requires a variety of skills necessary for providing equipment calibration, troubleshooting and maintenance support. This position will work in conjunction with Facilities, Engineering, Manufacturing, and Quality Departments.
Raw Materials; EM; Shipping; Equipment maintenance and basic manufacturing tasks
CCHMC SALARY GRADE:6
Regulated manufacturing processing; testing and other related tasks; analyze data; equipment maintenance; record-keeping.
Performs routine calibration and preventive maintenance on multiple systems including refrigerators, freezers, incubators, scales, centrifuges, and other miscellaneous benchtop instruments.
Performs Temperature Mapping Studies on temperature controlling environments such as: freezers, refrigerators, incubators, and warehouses.
Performs equipment troubleshooting, coordinating vendor technicians while ensuring work meets internal standards and work performed is properly documented.
Assists with onboarding new equipment and retiring obsolete equipment.
Works closely with facility and lab personnel to ensure collaborative and timely completion of scheduled and on demand maintenance activities.
Partners with Quality and Manufacturing for all cGMP equipment corrective maintenance and OOT investigations and documentation.
Develops, executes, and writes SOPs and Qualification Documents (IQ/OQ/PQ).
Provides support and training to peers to improve their abilities and increase their technical knowledge
Demonstrates working knowledge of GMP regulations.
Position requires clean room gowning during performance of some job duties (shoe coverings, coverall, head covering, safety glasses, gloves).
Other related duties as assigned.
Required: ???Bachelor's degree in a related field ??? 0 - 2 years of work experience in a related job discipline
GMP experience working in a biopharmaceutical facility or equivalent experience in a regulated industry.
Proficient computer skills utilizing MS Office suite applications.
Experience working within a Computerized Calibration and Maintenance Management System.
Validation experience is a plus.
Demonstrated mechanical aptitude with ability to analyze, investigate and solve equipment technical issues.
At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better, and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children’s.