Process Equipment Maintenance Technician I (DPI)

United Therapeutics•Rtp, NC

2d•Onsite

About The Position

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.

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

Nice To Haves

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

Responsibilities

Execute planned and unplanned routine maintenance and repairs on manufacturing, filling, assembly and packing/kitting lines.
Ensure timely completion of maintenance events.
Document maintenance events utilizing a Computerized Maintenance Management System (CMMS).
Maintain an accurate spare parts inventory.
Assist in identifying areas of improvement in the set-up and maintenance of cGMP equipment.
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.
Troubleshoot and diagnose mechanical, electrical, and operational issues on production equipment.
Obtain maintenance proposals, approval of purchase orders for proposals, and procurement of spare parts inventory from external vendors.
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.
Provide support in the completion of validations and special projects, audits, and other requirements.