Senior Equipment Systems & Vendor Associate

Senior Equipment Systems & Vendor Associate

United Therapeutics is the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. 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. Miromatrix, a United Therapeutics company was created to bring our vision of a world without an organ transplant waitlist to life. With an average of 17 people dying each day waiting for a life-saving organ, the need for a solution is more critical than ever. Founded in 2009 from the University of Minnesota's breakthrough advances in perfusion decellularization and recellularization technology, we are the world leader in the research and development of fully biologic organs. Our technology has the potential to be applied across the spectrum of donor needs. We are focused on the research and development of transplantable kidneys (mirokidney®), livers (miroliver®), and a bioengineered external liver assist device for acute liver failure (miroliverELAP®), with plans to also bioengineer other critical organs like lungs, pancreases and hearts.

The Senior Equipment Systems & Vendor Associate serves as a system owner and subject matter expert for maintenance, calibration, and equipment documentation platforms, and as the primary interface for external service providers supporting GMP equipment. This role ensures that computerized maintenance/calibration systems and associated records accurately reflect the current state of equipment, events, and documentation, and that vendor services are effectively scheduled, tracked, and compliant with internal and regulatory expectations. The Senior Equipment Systems & Vendor Associate partners closely with equipment owners, Quality, Supply Chain, and external vendors to maintain data integrity, drive on time completion of planned activities, and resolve issues related to certificates, contracts, and equipment purchases.

Ensure maintenance, calibration, and equipment tracking systems accurately reflect the current state of work, including equipment status, upcoming events, and completed activities.

Manage preventive maintenance, calibration, and vendor service schedules, communicate plans and changes to equipment owners, and actively drive on-time completion of all scheduled work.

Monitor and follow up on open activities, vendor certificates, and documentation gaps to ensure timely closure in accordance with requirements.

Accurately document executed work in designated systems, confirming tasks, parts, labor, and results are captured in alignment with established procedures and data integrity expectations.

Administer user accounts and access rights for equipment and maintenance systems, performing periodic reviews and timely updates to maintain appropriate role-based access.

Support system validation, upgrades, and configuration changes through participation in requirements definition, testing, documentation, and change control activities.

Organize and maintain executed equipment records, certificates, and manuals to ensure information is current, readily retrievable, and inspection ready.

Collaborate with Procurement and Finance to manage vendor commercial documentation including quotes, purchase orders, contracts, service agreements, and certificates of insurance.

Schedule and coordinate external vendor activities, manage site logistics, and ensure vendors comply with site safety, security, and GMP expectations.

Track and manage warranty-related issues such as faulty equipment, returns, exchanges, and associated documentation, driving timely resolution.

Facilitate communication between vendors and site stakeholders including Manufacturing, R&D, Quality, and Supply Chain to resolve service documentation, calibration reports, and related issues.

Identify and implement improvements to system workflows, documentation practices, and vendor processes to enhance efficiency, data integrity, and compliance.

Minimum Requirements:

• 6+ years of experience in equipment lifecycle management, with demonstrated ownership of systems, vendor services, and inspection readiness activities in a GMP-regulated pharma, biotech, or medical device environment with a H.S. Diploma/GED; or
• 5+ years of experience in equipment lifecycle management, with demonstrated ownership of systems, vendor services, and inspection readiness activities in a GMP-regulated pharma, biotech, or medical device environment with an Associate's Degree; or
• 4+ years of experience in equipment lifecycle management, with demonstrated ownership of systems, vendor services, and inspection readiness activities in a GMP-regulated pharma, biotech, or medical device environment with a Bachelor's Degree

Strong systems aptitude with a high attention to data accuracy and detail.

Demonstrated ability to anticipate upcoming needs and events and proactively plan and prepare to ensure readiness and timely execution.

Ability to manage multiple tasks and deadlines to on-time completion across multiple functional areas and teams.

Demonstrated ability to effectively prioritize competing priorities and drive on-time completion across diverse functional areas and teams.

Excellent interpersonal, communication, and cross-functional collaboration skills.

Strong organizational and time management skills.

Preferred Qualifications:

• Experience using BMRAM (Blue Mountain RAM) equipment management software.
• Experience driving schedules and activities cross-functionally to achieve on-time results.
• Experience managing vendor commercial documentation including contracts, purchase orders, quotes, certificates of insurance.

This position is 100% onsite at our Eden Prairie, Minnesota office. The salary for this position ranges from $65,000 to $85,000 per year and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.