Provide support to all aspects of the manufacturing and facilities maintenance efforts at the Raleigh, NC plant. Provide a safe and quality environment for the department employees at this site. This position will provide support to all departments; will interact with vendors, contractors and other personnel in a professional manner. Always be quality and safety orientated about actions that involve repair/maintenance or modifications to any systems or equipment.
Operate, maintain, and repair plant utility systems, including but not limited to: boilers, compressed air, pumping systems, chillers, HVAC units, hot water system, clean steam generators, PW pretreatment system, WFI stills, waste water systems, vacuum system, emergency power system
Independently maintain and repair production equipment as needed, including but not limited to: aseptic filling equipment, vial washers, depyrogenation tunnels, lyophilizers, cappers, tray loading, storage tanks, autoclave sterilizers, and component parts washers.
Perform general facility repairs (Lighting, Doors, Card reader, Security, Fire system).
Write preventive maintenance job plans and perform preventive maintenance on equipment and systems.
Work with Manager to use and administer Computerized Maintenance Management Software.
Interact with contractors, vendors and OEM techs as needed to complete PMs and repairs.
Source and order parts when needed to help maintain spare parts inventory and effect repairs.
Maintain Maintenance and Utility area cleanliness.
Interact with other departments and participate on working teams, when needed.
Execute small projects independently, when requested.
Available for 24 hr. call in when requested and meet attendance requirements for the job.
Understand and assist in implementing safety procedures and cGMP's
Obtain and maintain aseptic gowning qualification as needed.
Understand and execute demonstrated aseptic behaviors and techniques.
Technical vocational certificates in a maintenance related fields, such as welding, HVAC, electronics, or refrigeration, or equivalent education or experience.
Ten (10) years maintenance experience in facilities, utilities, HVAC, industrial equipment or controls.
Eight (8) years of cGMP maintenance experience with broad knowledge of facilities, clean utilities, HVAC, industrial equipment and controls in a pharmaceutical operation, with vial filling and lyophilizer operation experience preferred.
Ability to read, understand, and interpret mechanical and electrical drawings and PLC logic.
Physical requirements include ability to lift at least 75lbs and have excellent balance.
Must be able to pass aseptic gowning qualification.
Strong mechanical and/or electrical or controls systems aptitude and knowledge.
Ability to apply analytical reasoning and root cause analysis to solve problems.
Demonstrated ability to read, understand, interpret and apply technical writing and instruction.
Accurate attention to detail, and a strong understanding of pharmaceutical production.
Strong verbal and written communication skills, with knowledge of cGMPs, and the ability to follow good documentation practices.
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Role: Maintenance Mechanic
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