The Maintenance Specialist at Cook Incorporated will support, train, and provide continuous improvement support to the Maintenance Department, facilitate the maintenance and repair of facilities, utilities equipment, and help maintain quality and regulatory compliance. This position is primarily responsible for the advanced understanding, execution and continual improvement of facilities, utilities and maintenance performance.
• Oversee in-house maintenance of facilities, utilities equipment or systems as needed and provide support, guidance and direction to engineering, operations on new and existing assests• Oversee the preventative maintenance program which tracks all assets associated with cGMP and non-cGMP equipment and systems• Perform preventative maintenance on facilities, utilities, equipment, etc. as needed• Write QSPs, preventative maintenance instructions, deviation/failure investigations, change control documentation, and reportsInterface with various business functions including Facilities, Operations, Production Engineering, R&D, Quality, and Administration teams• Correspond with approved service suppliers to ensure preventative maintenance of equipment, instruments, or systems are maintained appropriately• Develop and analyze metrics to use to drive improvements• Serve as lead process owner or co-process owner within the quality management system for functional sub department• 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
• Bachelor's degree in technical discipline related to facilities management or a comparable combination of education, background, training and experience• 5years of experience in facilities maintenance• Proficient in or good working knowledge of Asset Management Software administration and management• 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• Knowledge of Microsoft Word, Excel, and Outlook
Physical Requirements:
• Ability to travel approximately 20% as necessary to other facilities• 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. • Personal protective equipment including safety glasses, lab coat and gloves may be required in some areas associated with this position