Process Equipment Maintenance Technician I (DPI)

Maintenance Equipment Technician I (DPI)

California, US residents click here. The job details are as follows:

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

You are a hands-on, proactive and detail-oriented maintenance professional who takes pride in keeping critical manufacturing equipment running safely, efficiently, and in compliance. In this role, you'll support the production of Tyvaso DPI by troubleshooting, maintaining, and improving manufacturing, filling, assembly, and kitting equipment in a cGMP environment. You'll work closely with experienced mechanics, operations teams, quality partners, and vendors to resolve equipment issues, support validation and improvement projects, and ensure maintenance activities are accurately documented through CMMS systems. This is an excellent opportunity for someone who enjoys problem-solving on the floor, learning from senior technical experts, and contributing directly to the reliable supply of an important medicine for patients.

The Process Equipment Maintenance Technician I (DPI) executes planned and unplanned routine maintenance and repairs on manufacturing, filling, assembly and packing/kitting lines to ensure the efficient production and supply of Tyvaso DPI medicine. This role works closely with the Lead and Senior Mechanic to ensure (a) timely completion of maintenance events, (b) documentation of events progressed utilizing a Computerized Maintenance Management System (CMMS) and (c) maintenance of an accurate spare parts inventory. They will assist in identifying areas of improvement in the set-up and maintenance of cGMP equipment, and provide operational support for validation and other projects. Assist with equipment operations and work with stakeholders and vendors to anticipate and resolve mechanical and automated equipment issues while adhering to cGMPs. This includes understanding the role equipment and systems play in meeting CPPs (certificate of pharmaceutical product) and other regulatory guidelines. With moderate supervision, perform preventative maintenance on equipment and update BMRAM to maintain accurate records. Troubleshoot and diagnose mechanical, electrical, and operational issues on production equipment with moderate supervision, ensuring problems are addressed quickly and effectively. Maintain proficiency with all responsibilities related to the GMP Maintenance activities. Assist with obtaining maintenance proposals, approval of purchase orders for proposals, and procurement of spare parts inventory from external vendors that are needed to support DPI manufacturing and kitting equipment. Escort external vendors during site visits to perform maintenance related activities on production equipment. Provide support on quality events/deviations, change controls, CAPAs and action items in TrackWise related to DPI manufacturing and kitting as needed to support manufacturing and production. Provide support in the completion of validations and special projects, audits, and other requirements. This may include some travel to other UT or vendor sites.

Minimum Requirements

H.S. Diploma or General Education Degree (GED) 2+ years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment Proficient in all Microsoft Office applications Experience in troubleshooting and repair of pneumatic, electronic and hydraulic control systems Ability to work well independently with minimal supervision as well as in a heavily team-focused environment Demonstrated working knowledge in the use of test equipment such as digital voltmeters, temperature probes and pneumatic calibrators Customer focused, with ability to multi-task and maintain a high quality of work Strong organization and problem-solving skills Proficient written and verbal communication skills with the ability to communicate effectively across all levels and functions of business

Preferred Requirements

Associate Degree in mechanical, or technical vocational studies in related field Experience with automation systems and platforms Ability to troubleshoot and operate complex automation systems Experience using a regulated database such as BMRAM or Cal Man

Job Location United Therapeutics requires this candidate to be on-site at our RTP, North Carolina location 100% of the time.

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