Sterility Assurance Specialist

Overview

The primary function of the Sterilization Specialist at Cook Incorporated is to support, train, and provide continuous improvement support to the Sterilization Department. Facilitate all routine and unscheduled maintenance activities for the sterilization department. Responsible for upkeep of maintenance scheduling, spare parts inventory, and work order traceability. Communicate all maintenance activities with sterilization management and coordinate tasks based on sterilization production needs. Monitor controlled parameters of the department. Assist in calibration and repair of Inspection, Measurement and Test Equipment, (IM&TE) and help maintain quality and regulatory compliance. Responsible for giving guidance to sterilization maintenance technician as necessary.

Responsibilities

• Oversee the sterilization maintenance scheduling for scheduled preventative maintenance as well as unscheduled maintenance• Oversee the management of the maintenance program which tracks all PMs and WOs associated with sterilization equipment and systems• Develops maintenance methods and procedures• Responsible for troubleshooting, maintaining, and repairing process and facility equipment for a safe and productive work environment• Disassemble mechanical equipment and tools, repair or replace worn or broken parts, and reassemble• Monitor, track, document any excursions in Building Monitoring System and ViewLink regarding sterilization department monitoring• Write QSPs, maintenance instructions, deviation/failure investigations, change control documentation, and reports• Interface with various business functions including Facilities, Production Engineering, R&D, Quality, and Administration teams• Correspond with approved service suppliers to ensure maintenance of equipment are maintained appropriately• Develop, analyze metrics, and to use to drive improvements• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements• Ability to work overtime as required• Must strictly adhere to safety requirements

Qualifications

• Bachelor Degree in a technical discipline related to instrumentation, maintenance/calibration, or a comparable combination of education, background, training and experience• 8-10 years of experience in maintenance or calibration• Ability to read and interpret machine manuals/schematics, electrical blueprints/schematics and process control diagrams• Ability to safely operate hand tools and power tools• Excellent organizational and time management skills• Advanced understanding of cGMP, CFR 820 and ISO regulations and working with engineering to develop procedures and process for advanced equipment and future state growth• Proficient in or good working knowledge of Computerized Maintenance Management Software (CMMS) administration and management• Knowledge of Microsoft Word, Excel, and Outlook

Physical Requirements:

• Must be able to perform reasonable job functions requiring periods of sitting, standing, walking, hearing, and utilizes close visual acuity for working with computers, etc.• Able to lift and/or move more than 50 pounds occasionally• Personal protective equipment including respiratory protection, safety glasses, lab coat, gloves and appropriate shoes may be required in areas associated with this position