Mechanic II, Maintenance (DPI)

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 Mechanic II, Maintenance is primarily responsible for timely completion of preventive maintenance, intermediate level troubleshooting, and highly effective repairs of GMP manufacturing equipment, clean utilities, and all associated support systems. 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 support monitoring & maintaining 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 and properly by following established processes and monitoring and inspecting equipment and facilities
• Complete assigned preventive and corrective maintenance activities and accurately document work performed in the computerized maintenance management software (CMMS) in accordance with policies and instructions
• Troubleshoot equipment and perform effective repairs on manufacturing equipment and associated support systems and utilities with limited supervision
• Assist with monitoring and maintaining boiler system operations, including chemical testing and charging brine tanks for feed water softeners as assigned
• Escalate and seek guidance on the most complex tasks and projects when needed to complete work safely and effectively
• Adhere to applicable standard operating procedures (SOPs) and attend and fully participate in all assigned training
• Maintain facility and production systems in accordance with applicable cGMP requirements
• Ensure that vendors and contractors are trained in applicable company procedures regarding safety, environmental, and health in order to provide effective service in compliance with all ordinances such as electrical and construction codes
• Assist with special projects and construction projects, which may include demolition, renovation, and new construction
• 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)
• 4+ years of experience as maintenance personnel in an industrial, pharma/bio, or manufacturing environment
• Active Driver License, valid and in good standing
• Intermediate knowledge of cGMP and ISO regulatory requirements
• Intermediate ability to troubleshoot systems and components to ensure the safe and proper operation and adherence to building and local codes
• Intermediate ability to work independently on projects or assignments without close supervision or detailed instructions to maximize workplace productivity
• 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)
• Fundamental computer skills and ability to use tablet devices
• Intermediate understanding of equipment and methods of operation, including but not limited to: manufacturing/process equipment, BMS/BAS, fire/life safety, purified water, environmental monitoring, and other systems

Preferred Qualifications

• Associate degree in advanced technical training
• 4+ years of experience in the pharmaceutical/medical device industry (preferred)

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.