Provide leadership to process maintenance and utility operators to maintain good group moral and safetyImproves the performance of production lines and critical utilities by using effective preventative maintenance, timely problem solving, equipment improvements, and training of production and maintenance personnel as needed.Maintain the facility and grounds at an acceptable level by preventative maintenance and unscheduled Work OrdersCoordinate and schedule outside services when needed to support the efforts of the facility mechanics and utility operators.Provide utilities support to the plant on a consistent and reliable basisActively participate in all Environmental, Health, and Safety aspects of the plant.Ensures productivity of maintenance department through implementation of a maintenance excellence program, maintenance planning and work order assignments to process mechanics.Provides maintenance support to all aspects of the manufacturing process in accordance with FDA guidelines, current Good Manufacturing Practices (cGMP), and all internal operating procedures.Provides technical direction, effective problem solving/troubleshooting, and training for process mechanicsDepartment Specific/Non-Essential Functions:Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and-or environmental incidents to management immediately.Maintain compliance within Engineering and Maintenance systems (e.g., job plans, PM records, work orders).Enforce EHS procedures and respond to EHS concerns within his/her area of operational responsibility. Conduct incident investigations for all incidents that may occur within his/her department. Follow through on all safety related corrective actions in his/her department.Collaborate with Quality, Validation, Production, and EHS for compliance initiatives.Participate in corporate or site-wide audits, CAPA reviews, and training sessions as required.Other duties as assigned with or without accommodation
4-7 years
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Engineering or technical degree or equivalent years of experience in lieu of degree5+ years of experience in maintenance and a regulated pharmaceutical, biotechnology, or medical device environment.Solid understanding of GMP, FDA, and ISO regulations.Strong experience with maintenance and calibration systems (e.g., CMMS such as Maximo).Excellent analytical, organizational, and communication skills.Strong attention to detail and ability to manage multiple priorities.Experience in understanding and troubleshooting Distributed Control Systems (Foxboro I/A System preferred) and PLCs (Allen-Bradley preferred)
No Degree Required
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