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

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 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 (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 in DPI manufacturing and kitting operations.
• 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 TrackWise 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

Minimum Requirements

• H.S. Diploma or General Education Degree (GED)
• Experience requirements for GMP Maintenance Technician II level:
  • Minimum 4 years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment
• Experience requirements for Senior GMP Maintenance Technician level:
  • Minimum 6 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, 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 functions and with external vendors
• Ability to provide guidance or technical support to less experienced technicians

Preferred Qualifications

• Associate degree in life science, mechanical, or technical vocational studies in related field
• Experience with automation systems and platforms
• Advanced ability to troubleshoot and operate complex automation systems and resolve non-routine issues
• Experience using a regulated database such as BMRAM or Cal Man
• 4+ years of experience in the pharmaceutical/medical devices industry

Location

United Therapeutics requires this candidate to be 100% on-site at our Durham, NC office.

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.

United Therapeutics is an equal opportunity employer committed to diversity and inclusion. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.