GMP Maintenance Technician II; DPI​/Senior GMP Maintenance Technician; DPI

Job Title

GMP Maintenance Technician II (DPI) / Senior GMP Maintenance Technician (DPI)

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.

The GMP Maintenance Technician II (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 Mechanics team members to ensure timely completion of maintenance events, documentation of events progress utilizing a Computerized Maintenance Management System (CMMS), and maintenance of an accurate spare parts inventory.

The technician 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.
• Perform preventative maintenance on equipment and update BMRAM to maintain accurate records with limited supervision.
• Troubleshoot and diagnose mechanical, electrical, and operational issues on production equipment, applying technical judgment to resolve non‑routine issues and ensuring problems are addressed quickly and effectively.
• Maintain proficiency with all responsibilities related to GMP Maintenance activities and apply working knowledge to improve equipment performance and reliability.
• Assist with obtaining maintenance proposals, approval of purchase orders, and procurement of spare parts inventory from external vendors that are needed to support DPI manufacturing and kitting equipment.
• Coordinate with 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 Track Wise related to DPI manufacturing and kitting, including investigation support and follow‑up actions.
• Provide support in the completion of validations and special projects, audits, and other requirements, contributing to execution and documentation. This may include some travel to other UT or vendor sites.
• Perform other duties as assigned.

• H.S. Diploma or General Education Degree (GED)
• Minimum 4 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, including diagnosing non‑routine issues
• Demonstrated working knowledge in the use of test equipment such as digital voltmeters, temperature probes and pneumatic calibrators
• Customer focused,…