Lead CMMS Specialist, GMP

United Therapeutics•Silver Spring, MD

1d•$82,000 - $110,000

About The Position

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 manufactured 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. Who You Are: You are a BM-RAM systems aficionado. You are detail oriented, organized and love living in the details. This role is a new role looking for someone who wants to make an impact while getting to see and be part of how the sausage is made as part of so many of our incredible teams you have read about and are on track to change the world. This role is an incredible opportunity for someone with strong communication skills who loves to collaborate and be part of the big picture while supporting both existing and oncoming sites. How you’ll contribute The Lead CMMS Specialist, GMP, provides advanced Blue Mountain Regulatory Asset Manager (BM-RAM) and documentation support across multiple GMP-regulated UT sites. This role performs day-to-day CMMS updates, maintains high-quality equipment and task records, and supports consistent system use across teams with varying levels of BM-RAM proficiency. Reporting to the Manager, Facilities Programs & Operations, this role executes system updates as directed by relevant stakeholders, supports users with data entry and workflow questions, and conducts routine data integrity reviews to maintain audit-ready BM-RAM records. The position collaborates closely with Maintenance, Calibration, Facilities, Operations, Quality, Validation, and R&D to ensure BM-RAM data accurately reflects approved requirements and operational expectations. This role requires strong attention to detail, independent execution, and the ability to support multiple sites in a fast-moving, compliance-focused environment.

Requirements

10+ years of experience in facilities, maintenance, calibration, or GMP operations with regular use of CMMS platforms, including equipment record updates, workflow execution, and support of compliance-driven documentation with a H.S. Diploma or GED or 8+ years of experience in facilities, maintenance, calibration, or GMP operations with regular use of CMMS platforms, including equipment record updates, workflow execution, and support of compliance-driven documentation with an Associate Degree or 6+ years of experience in facilities, maintenance, calibration, or GMP operations with regular use of CMMS platforms (e.g., BM-RAM, Maximo, SAP PM), including equipment record updates, workflow execution, and support of compliance-driven documentation with a Bachelor's Degree
BM-RAM or equivalent CMMS platform proficiency
Ability to coach BM-RAM users at varying skill levels
Understanding of GMP documentation requirements
Familiarity with facilities, maintenance, and calibration operations in regulated environments
Knowledge of asset hierarchies, equipment terminology, and PM structures
High proficiency in CMMS data entry and system navigation
Ability to independently identify data quality issues and escalate appropriately
Strong analytical and problem-solving capabilities
Proficiency with Microsoft Office (Teams, Excel, Word)
Ability to follow established procedures and implement system updates as directed
Effective written and verbal communication
Ability to collaborate across UT sites
Ability to maintain confidentiality and manage sensitive records

Nice To Haves

Strong organizational and prioritization skills

Responsibilities

Perform day-to-day Blue Mountain Regulatory Asset Manager (BM-RAM) administrative activities, including asset setup, lifecycle updates, preventive maintenance and calibration schedule implementation, WPT updates, metadata cleanup, and accurate execution of all system changes as directed by Maintenance, Calibration, and Site Facilities owners
Compile, update, and maintain GMP-compliant calibration and maintenance records, ensuring documentation accuracy, completeness, legibility, and traceability.
Execute updates to controlled documents, templates, and instructions as directed and maintain audit-ready files for supported groups
Provide daily system and documentation support to BM-RAM users across multiple sites, including troubleshooting workflow issues, guiding proper data entry, and assisting new or inexperienced users with system navigation and established procedures
Implement standardized BM-RAM workflows, WPT structures, asset metadata rules, and documentation practices across sites with varying levels of system maturity, ensuring consistent execution of approved processes and enterprise expectations
Perform routine data integrity reviews to verify record accuracy and completeness, execute corrective updates as instructed, and retrieve and organize BM-RAM records to support internal and external audit activities
Coordinate with Maintenance, Calibration, Facilities, Operations, Quality, Validation, R&D, and other stakeholders to ensure BM-RAM data, schedules, and records accurately reflect approved requirements and operational needs
Provide additional system, documentation, or data support activities as assigned, including assistance with cleanup efforts, minor system updates, or cross-functional initiatives consistent with role scope
Perform all other duties as assigned

Benefits

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.
For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

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