Lead Mechanic, Maintenance

United Therapeutics•Rtp, NC

2d•Onsite

About The Position

The Lead Maintenance Mechanic will interface between end user, Facilities staff, Facilities Management, and vendors. This position will provide advanced technical support and oversight in regard to operating, maintaining, troubleshooting, installing, or repairing manufacturing/processing systems and equipment. Manufacturing equipment may include but is not limited to bioreactors, blow-fill-seal machines, autoclaves, fluid bed processors, pan coaters, tablet presses, robotic aseptic filling lines, aseptic vial filling lines, automatic visual testing equipment, etc. (relative to specific site operations). This role will also assist Facilities management in planning and overseeing maintenance of all base utilities, buildings, electrical systems, water systems (incoming, pure, & waste), steam systems, HVAC & refrigeration, Life Safety Systems, and grounds as necessary in a cGMP Facility. Ensure production and facility systems operate efficiently, properly, and are cGMP compliant by following set processes in addition to monitoring and inspecting equipment and facilities.

Requirements

H.S. Diploma or General Education Degree (GED)
8+ years of experience as maintenance personnel in an industrial, pharma/bio, or manufacturing environment
High level knowledge of cGMP and ISO regulatory knowledge
Strong ability to successfully interact with various levels of employee and managements
Strong ability to convey complex technical information in an easily understood manner
Strong ability to interpret and achieve internal and external clients or customers’ needs and expectations during product or service development, manufacturing, marketing, delivery, and/or support
Highly effective ability to troubleshoot MEP/cGMP systems and components to ensure the safe and proper operation and adherence to building and local codes
Extremely competent working independently on projects or assignments without close supervision or detailed instructions to maximize workplace productivity
Strong ability to maintain records and reports (e.g., time sheets, daily work orders, time reports) to provide information and documentation and to comply with departmental policies
Ability to work in an environment that includes dust and other debris using Personal Protective Equipment (PPE) in the installation, maintenance, alteration, and repair of building/facility systems
Ability to adhere to all regulatory and compliance requirements defined in Good Manufacturing Practices (cGMPs)
Willingness to learn new concepts to fully understand aseptic technique and demonstrate proper cleanroom behavior
Ability to follow and execute Standard Operating Procedures (SOPs)
Proficient computer skills and ability to use tablet devices
Strong working knowledge of Building Automation Systems

Nice To Haves

Associates Degree in advanced technical training
8+ years of experience in the pharmaceutical/medical devices industry

Responsibilities

Complete assigned preventive & corrective maintenance and provide proper documentation of work performed in the computerized maintenance management software (CMMS) in accordance with policies and instructions
Troubleshoot and resolve complex, multi-faceted technical problems related to manufacturing/processing equipment & systems
Serve as the senior subject matter expert (SME) regarding manufacturing/processing systems & equipment in collaboration with internal or external resources as necessary
Train, mentor, and coach technicians on equipment maintenance, troubleshooting, documentation, and customer service. May evaluate and assign tasks to other technicians as needed
Assist or perform monitoring and maintaining boiler system including chemical testing and charging of brine tanks for feed water softeners as assigned
Assist Facility Manager with planning, documenting, and implementing planned maintenance
Assist Facilities Management in researching recommend upgrades or improvements and required spare parts to ensure maximum reliability and efficiency
Ensure outside vendors and contractors are trained in applicable procedures regarding safety, environmental, and health. Monitor vendors and outside contractors to ensure compliance with all ordinances such as UT procedures & policies and electrical & construction codes
Participate in emergency and after hours on-call rotation in order to ensure continuous operations of facility and production systems
Perform other duties as assigned