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

Job Details

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

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.

Responsibilities

• 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 (GMP Maintenance Technician II (DPI))

• 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, 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 (GMP Maintenance Technician II (DPI))

• Associate Degree in mechanical or technical vocational studies
• 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

Minimum Requirements (Senior GMP Maintenance Technician (DPI))

• H.S. Diploma or General Education Degree (GED)
• Minimum 6 years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment
• Proficient in all Microsoft Office applications
• Experience with automation systems and platforms
• 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
• Ability to troubleshoot and operate complex automation systems
• 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
• Experience using a regulated database such as BMRAM or Cal Man
• 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 Qualifications (Senior GMP Maintenance Technician (DPI))

• Associate Degree in life science, mechanical, or technical vocational studies in related field
• 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.

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.