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

United Therapeutics•Rtp, NC

11d•Onsite

About The Position

United Therapeutics (Nasdaq: UTHR) is seeking a GMP Maintenance Technician II (DPI) or Senior GMP Maintenance Technician (DPI) to join their team. This role is crucial for ensuring the efficient production and supply of Tyvaso DPI medicine by executing planned and unplanned routine maintenance and repairs on manufacturing, filling, assembly, and packing/kitting lines. The position involves close collaboration with the Mechanics team, meticulous documentation using a Computerized Maintenance Management System (CMMS), and maintaining an accurate spare parts inventory. The technician will also contribute to identifying areas for improvement in cGMP equipment setup and maintenance, provide operational support for validation and other projects, and assist with equipment operations. A key aspect of this role is understanding how equipment and systems impact critical process parameters (CPPs) and regulatory guidelines in DPI manufacturing and kitting operations. The company is a public benefit corporation focused on developing novel pharmaceutical therapies and technologies for rare, deadly diseases and expanding the availability of transplantable organs.

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 Technician II)
Minimum 6 years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment (for Senior 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 (for Technician II)
Proficient written and verbal communication skills with the ability to communicate effectively across all levels and functions of business (for Senior Technician)
Ability to provide guidance or technical support to less experienced technicians (for Technician II)
Ability to work well independently with minimal supervision as well as in a heavily team-focused environment (for Senior Technician)
Ability to troubleshoot and operate complex automation systems (for Senior Technician)
Experience using a regulated database such as BMRAM or Cal Man (for Senior Technician)

Nice To Haves

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

Responsibilities

Execute planned and unplanned routine maintenance and repairs on manufacturing, filling, assembly, and packing/kitting lines.
Work closely with Mechanics team members to 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 with limited supervision.
Troubleshoot and diagnose mechanical, electrical, and operational issues on production equipment, applying technical judgment to resolve non-routine issues.
Ensure 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.
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.
Perform other duties as assigned.