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Lead CMMS Specialist, GMP

Job in Silver Spring, Montgomery County, Maryland, 20900, USA
Listing for: United Therapeutics Corporation
Full Time position
Listed on 2025-12-08
Job specializations:
  • Business
    Data Analyst, Data Scientist
Job Description & How to Apply Below
Lead CMMS Specialist, GMP page is loaded## Lead CMMS Specialist, GMPremote type:
Remote locations:
Silver Spring, MD:
RTP, NCtime type:
Full time posted on:
Posted Todayjob requisition :
R04487

California, US residents .
** The job details are as follows:
**** Who We Are
** 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.
* 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…
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