As the Lead Calibration Specialist, you will oversee the optimal operation, maintenance, and calibration of facility instrumentation and measurement systems supporting GMP manufacturing of Radiopharmaceuticals at the Indianapolis site. Your role involves leading first-line response and troubleshooting for all process & non-process instrumentation and calibration equipment. You will also lead calibration planning, scheduling, and execution for both new and existing equipment, including developing calibration protocols, maintaining calibration records, and verifying compliance with GMP, EHS, and NRC standards. You will manage and supervise contract service providers responsible for calibration activities, ensuring their adherence to regulatory and internal standards. This includes inspecting their work, ensuring compliance, and handling the appropriate documentation for the CMMS and other GMP systems. In addition, you may assist with the commissioning, qualification, and validation of new instrumentation and measurement equipment. You will also support the maintenance of GMP manufacturing equipment, maintain accurate calibration logs and spare parts inventory within the CMMS, and assist with waste management and removal processes regarding calibration and instrument waste.
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Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees