Senior Mechanic, GMP Maintenance
IVIVA Medical
Senior Gmp Maintenance Technician (Dpi)
United Therapeutics seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant.
The Senior Gmp Maintenance Technician (Dpi) executes planned and unplanned 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 Mechanic to ensure timely completion of maintenance events, documentation of events progressed utilizing a Computerized Maintenance Management System (CMMS) and maintenance of an accurate spare parts inventory. As an SME, the Senior Process Equipment / Maintenance Technician will understand and be able to train other mechanics/technicians on the setup, operation, functional systems, and role of cGMP equipment. They will work to identify areas of improvement in the set-up and maintenance of cGMP equipment, and provide operational support for validation and other projects.
Minimum Requirements:
- H.S. Diploma or General Education Degree (GED)
- 6+ years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment
- 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:
- Associate Degree in life science, mechanical, or technical vocational studies in related field and 4+ years of experience in the pharmaceutical/medical devices industry
Job Location: Durham, North Carolina
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