Facilities Maintenance Specialist

2 weeks ago


Durham, North Carolina, United States CARsgen Therapeutics Full time

Position Summary:

We are seeking a highly skilled Facilities Maintenance Specialist to join our team at CARsgen Therapeutics' Durham facility. This technical role offers a great opportunity to grow your career within Maintenance and Engineering areas supporting leading-edge CAR-T therapy manufacturing. As a key member of our team, you will be responsible for prioritizing and coordinating the maintenance of process, facility, and analytical equipment at our GMP manufacturing facility. In this role, you will actively manage your schedule and external suppliers to reliably support facility/utility operations and production systems.

Key Responsibilities:

  • Coordinate maintenance activities with internal stakeholders and vendors within a GMP process facility.
  • Review controlled documentation for clarity and traceability.
  • Assist in developing and maintaining standard operating procedures (SOP) and equipment forms/logbooks for the department.
  • Maintain the computerized maintenance management system (CMMS) assets, PM schedule, maintenance work orders, and associated documentation.
  • Maintain the Vaisala Environmental Monitoring System.
  • Maintain facility drawings (P&ID's, Floorplans, etc.).
  • Assist with investigations and action items to support Deviations, CAPA's, and Change Controls.

Qualifications:

  • Bachelor's degree in engineering or life science related field and a minimum of three years of experience in a GMP manufacturing environment.
  • Experience with maintenance principles within a manufacturing and GMP process facility.
  • Previous experience working in a cleanroom or GMP/regulated manufacturing environment.
  • Strong communication and organizational skills.
  • Flexibility to perform various tasks and ability to prioritize based on business needs.
  • Analytical and technical skills to work through and troubleshoot equipment and instruments.
  • Experience maintaining supportive facility & utility equipment in a GMP regulated facility.
  • Experience with GMP process and analytical equipment such as incubators, refrigerators, and freezers, biological safety cabinets, small bioreactors, centrifuges.
  • Experience working with a CMMS and managing maintenance work orders and associated documentation.
  • Experience working with AutoCAD for drawing management is a plus.
  • Previous experience handling Deviations, OOT, CAPAs, and Change Controls for equipment within a QMS framework.
  • Ethics and Integrity.


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