United Therapeutics
Manager, Equipment Maintenance & Calibration
United Therapeutics, Eden Prairie, Minnesota, United States, 55344
Overview
We are United Therapeutics (Nasdaq: UTHR), a first publicly-traded biotech or pharmaceutical company formed as a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through 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; however, only a small percentage of donated organs are available. We are working to create bio-artificial organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant, with the goal of eliminating the transplant waiting list and curing end-stage organ diseases where transplant is not currently an option. Miromatrix, a United Therapeutics company, was created to bring this vision to life. With an average of 17 people dying each day waiting for a life-saving organ, the need remains critical.
Founded in 2009 from the University of Minnesota’s breakthrough advances in perfusion decellularization and recellularization technology, we are a leader in the research and development of fully biologic organs. Our approach aims to efficiently address the unmet needs of thousands of patients who would otherwise go without the transplant they need to survive and thrive. Miromatrix has 140 issued patents worldwide and focuses on the development of transplantable kidneys (mirokidney), livers (miroliver), and a bioengineered external liver assist device (miroliverELAP), with plans to bioengineer other critical organs like lungs, pancreases, and hearts.
Responsibilities
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, FAT, SAT, and IQ/OQ/PQ 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 (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 GMP compliance and alignment with in-house vs. contracted services.
Develop, implement, and maintain a maintenance training program. Ensure staff is cross-trained across GMP and non-GMP systems and equipment and on facility life safety systems. Provide internal and external training recommendations to develop technicians to improve in-house capabilities.
Direct the development of a system/equipment reliability program and metrics to track infrastructure upgrade needs. Recommend utilities system upgrades to drive reliability and efficiency improvements and minimize downtime.
Direct and manage direct reports including training, goal setting, performance evaluations, coaching, mentoring, and recruitment support as needed
Perform other duties as assigned
Minimum Requirements
Associate Degree in metrology or relevant engineering field with 10+ years of relevant industry experience OR a Bachelor's Degree in metrology or relevant engineering field with 8+ years of relevant industry experience
2+ years of people management experience
Organizational skills and systems implementation knowledge
Solid fundamental computer skills in word processing and spreadsheet handling
Ability to work in a team environment and collaborate with others throughout the organization
Demonstrated ability to analyze and solve technical problems
Effective verbal and written communication skills
Experience using metrology tools and standards
Preferred Qualifications
Bachelor’s Degree in metrology or relevant engineering field of study
Job Location This role can be located 100% onsite in Eden Prairie, MN.
Benefits Eligible employees may participate in the company’s comprehensive benefits suite, 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. For additional information on company benefits, please visit
https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
#J-18808-Ljbffr
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; however, only a small percentage of donated organs are available. We are working to create bio-artificial organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant, with the goal of eliminating the transplant waiting list and curing end-stage organ diseases where transplant is not currently an option. Miromatrix, a United Therapeutics company, was created to bring this vision to life. With an average of 17 people dying each day waiting for a life-saving organ, the need remains critical.
Founded in 2009 from the University of Minnesota’s breakthrough advances in perfusion decellularization and recellularization technology, we are a leader in the research and development of fully biologic organs. Our approach aims to efficiently address the unmet needs of thousands of patients who would otherwise go without the transplant they need to survive and thrive. Miromatrix has 140 issued patents worldwide and focuses on the development of transplantable kidneys (mirokidney), livers (miroliver), and a bioengineered external liver assist device (miroliverELAP), with plans to bioengineer other critical organs like lungs, pancreases, and hearts.
Responsibilities
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, FAT, SAT, and IQ/OQ/PQ 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 (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 GMP compliance and alignment with in-house vs. contracted services.
Develop, implement, and maintain a maintenance training program. Ensure staff is cross-trained across GMP and non-GMP systems and equipment and on facility life safety systems. Provide internal and external training recommendations to develop technicians to improve in-house capabilities.
Direct the development of a system/equipment reliability program and metrics to track infrastructure upgrade needs. Recommend utilities system upgrades to drive reliability and efficiency improvements and minimize downtime.
Direct and manage direct reports including training, goal setting, performance evaluations, coaching, mentoring, and recruitment support as needed
Perform other duties as assigned
Minimum Requirements
Associate Degree in metrology or relevant engineering field with 10+ years of relevant industry experience OR a Bachelor's Degree in metrology or relevant engineering field with 8+ years of relevant industry experience
2+ years of people management experience
Organizational skills and systems implementation knowledge
Solid fundamental computer skills in word processing and spreadsheet handling
Ability to work in a team environment and collaborate with others throughout the organization
Demonstrated ability to analyze and solve technical problems
Effective verbal and written communication skills
Experience using metrology tools and standards
Preferred Qualifications
Bachelor’s Degree in metrology or relevant engineering field of study
Job Location This role can be located 100% onsite in Eden Prairie, MN.
Benefits Eligible employees may participate in the company’s comprehensive benefits suite, 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. For additional information on company benefits, please visit
https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
#J-18808-Ljbffr