Lead Mechanic, Maintenance

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

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
• 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

Minimum 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

Preferred Qualifications

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

Job Location

United Therapeutics requires this candidate to be 100% on-site at our Durham, NC office and will require the ability to be on-call as needed.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.