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

About the role

The GMP Maintenance Technician II (DPI) and Senior GMP Maintenance Technician (DPI) roles at United Therapeutics are responsible for executing routine and unplanned maintenance on manufacturing, filling, assembly, and packaging/kitting lines. These positions require close collaboration with mechanics and stakeholders to ensure compliance with cGMPs and regulatory guidelines.

Responsibilities

• Execute planned and unplanned routine maintenance and repairs on manufacturing, filling, assembly, and packaging/kitting lines.
• Document maintenance events using a CMMS system and maintain an accurate spare parts inventory.
• Identify areas for improvement in equipment setup and maintenance, and provide operational support for validation and other projects.
• Assist with equipment operations and resolve mechanical and automated equipment issues while adhering to cGMPs.
• Perform preventative maintenance on equipment and update BMRAM to maintain accurate records.
• Diagnose and resolve non-routine issues on production equipment, applying technical judgment to ensure quick and effective problem resolution.
• Support quality events/deviations, change controls, CAPAs, and action items in TrackWise related to DPI manufacturing and kitting.
• Contribute to the completion of validations, special projects, audits, and other requirements, including investigation support and follow-up actions.
• Coordinate with external vendors during site visits to perform maintenance related activities on production equipment.
• Support the completion of validations and special projects, audits, and other requirements, including investigation support and follow-up actions.
• Perform other duties as assigned.

Requirements

• H.S. Diploma or 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

Preferred Qualifications

• 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

Benefits

United Therapeutics offers a competitive benefits package including health insurance, retirement plans, and paid time off.

Pay

Compensation is commensurate with experience.

Schedule

This position requires a full-time, on-site schedule at United Therapeutics' Durham, NC office.