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

Unither Pharmaceuticals

12d•Onsite

About The Position

United Therapeutics (Nasdaq: UTHR) is a public benefit corporation dedicated to developing novel pharmaceutical therapies and technologies for rare, deadly diseases and to expand the availability of transplantable organs. The GMP Maintenance Technician II (DPI) / Senior GMP Maintenance Technician (DPI) is responsible for executing 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 collaborates with the Mechanics team to ensure timely maintenance, accurate documentation in a CMMS, and efficient spare parts inventory management. The position involves identifying areas for improvement in cGMP equipment setup and maintenance, providing operational support for validation and other projects, and assisting with equipment operations. The technician will work with stakeholders and vendors to resolve mechanical and automated equipment issues while adhering to cGMPs, understanding the role of equipment in meeting regulatory guidelines for DPI manufacturing and kitting. Key responsibilities include performing preventative maintenance, troubleshooting mechanical, electrical, and operational issues, maintaining proficiency in GMP Maintenance activities, assisting with procurement of spare parts, coordinating with external vendors, and supporting quality events, deviations, change controls, CAPAs, validations, and special projects. Travel to other UT or vendor sites may be required.

Requirements

H.S. Diploma or General Education Degree (GED)
Minimum 4 years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment (for GMP Maintenance Technician II)
Minimum 6 years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment (for Senior GMP Maintenance Technician)
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 (for Senior GMP Maintenance Technician)
Ability to work well independently with minimal supervision as well as in a heavily team-focused environment (for Senior GMP Maintenance Technician)
Ability to troubleshoot and operate complex automation systems (for Senior GMP Maintenance Technician)
Experience using a regulated database such as BMRAM or Cal Man (for Senior GMP Maintenance Technician)

Nice To Haves

Associate Degree in mechanical or technical vocational studies (for GMP Maintenance Technician II)
Experience with automation systems and platforms (for GMP Maintenance Technician II)
Advanced ability to troubleshoot and operate complex automation systems and resolve non-routine issues (for GMP Maintenance Technician II)
Associate Degree in life science, mechanical, or technical vocational studies in related field (for Senior GMP Maintenance Technician)
4+ years of experience in the pharmaceutical/medical devices industry (for Senior GMP Maintenance Technician)

Responsibilities

Executes planned and unplanned routine maintenance and repairs on manufacturing, filling, assembly and packing/kitting lines.
Works closely with Mechanics team members to ensure timely completion of maintenance events.
Documents maintenance events utilizing a Computerized Maintenance Management System (CMMS).
Maintains an accurate spare parts inventory.
Assists in identifying areas of improvement in the set-up and maintenance of cGMP equipment.
Provides operational support for validation and other projects.
Assists with equipment operations and works with stakeholders and vendors to anticipate and resolve mechanical and automated equipment issues while adhering to cGMPs.
Performs preventative maintenance on equipment and updates BMRAM to maintain accurate records with limited supervision.
Troubleshoots and diagnoses mechanical, electrical, and operational issues on production equipment, applying technical judgment to resolve non-routine issues.
Maintains proficiency with all responsibilities related to GMP Maintenance activities and applies working knowledge to improve equipment performance and reliability.
Assists with obtaining maintenance proposals, approval of purchase orders, and procurement of spare parts inventory from external vendors.
Coordinates with external vendors during site visits to perform maintenance related activities on production equipment.
Provides 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.
Provides support in the completion of validations and special projects, audits, and other requirements, contributing to execution and documentation.
Performs other duties as assigned.