Manager, Equipment Maintenance & Calibration

Calibration Leader

We are 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 (Nasdaq : UTHR) 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 bio-artificial organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

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 (miroliver ELAP), with plans to also bioengineer other critical organs like lungs, pancreases and hearts.

We are looking for a calibration leader who thrives working at the center of it all. This position gets to work with the smartest humans, leading edge technology and learn something new and exciting daily! This position will be responsible for development and execution of maintenance, calibration, technical oversight, and asset management operations. Responsibilities include equipment procurement, troubleshooting, ongoing performance analysis to improve overall equipment reliability, as well as management and support coordination of maintenance activities with production and lab schedules. This role will focus on providing engineering / GxP administration for RAM in support of maintenance and projects.

Responsibilities include :

• Oversee and support preventative maintenance and keep accurate records of work completed
• Manage writing / completing equipment SOPs, change controls and deviations for GxP engineering and facilities operations
• Effectively communicate technical issues with equipment vendors and supporting departments during troubleshooting activities and maintenance / repair visits
• Execute and support calibration and validation efforts for production area equipment and processes
• Coordinate calibration and validation activities, serve as the validation subject matter expert in specific areas of equipment validation
• Collect, compile, analyze, and review data in support of validation activities. Analyze and interpret data and information through more sophisticated or in-depth analysis to confirm the validated state of the equipment for GMP use with some or minimal supervision.
• Develop, execute, and review various types of equipment lifecycle documentation, including but not limited to : SOPs, Master Plans, User Requirement and Functional Requirements Specifications, Design Specifications, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and Design Qualification (DQ), IQ, OQ, PQ, PV protocols and reports. Provide execution and documentation oversight of junior team members.
• Work independently on problems of diverse scope where analysis of data requires identification of root cause events. Select methods and techniques for problem-solving and decision-making.
• Perform gap analysis of validation documentation, systems, and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
• Support site audits / inspections (both internal and external authorities) as directed by Operations / QA to represent facilities and calibration departments
• Direct the development of an SOP review and alignment strategy. Support managing facilities, calibration, and tech services leads to maintain all utilities equipment and calibration SOPs to ensure compliance with GMP standards, quality systems and that SOPs align with in-house vs. contracted services.
• Develop, implement, and maintain a maintenance training program. Ensure staff is cross-trained across both GMP and non-GMP systems and equipment and on facility life safety systems. Create internal and external training recommendations to develop technicians to improve in-house capabilities.
• Direct the development of system / equipment reliability program and metrics to track infrastructure upgrade needs. Make recommendations for utilities systems upgrades to drive reliability and efficiency improvements and minimize system downtime.
• Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations / management, coaching, mentoring, career development and provide support for recruitment process (as needed)
• Perform other duties as assigned

Minimum requirements include :

Preferred qualifications include :

This role can be located 100% onsite in Eden Prairie, MN.

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.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.