Senior Process Engineer

2 weeks ago


Durham, North Carolina, United States CARsgen Therapeutics Full time

Position Overview:

The Senior Process Engineer at CARsgen Therapeutics' facility plays a pivotal role in the technical aspects of CAR-T therapy production. This position offers an excellent opportunity for professional development within the Maintenance and Engineering sectors, focusing on cutting-edge manufacturing processes. The individual will be responsible for the prioritization and coordination of maintenance activities related to process, facility, and analytical equipment within a GMP environment. Effective management of schedules and collaboration with external suppliers is essential to ensure the reliability of facility operations and production systems. Proficiency in the computerized maintenance management system is crucial for overseeing maintenance operations.

Key Responsibilities:

  1. Facilitate maintenance operations in collaboration with internal teams and external vendors within a GMP manufacturing environment.
  2. Conduct thorough reviews of controlled documentation to ensure clarity and traceability.
  3. Support the creation and upkeep of standard operating procedures (SOPs) and equipment documentation for the department.
  4. Oversee the management of CMMS (Blue Mountain Regulatory Asset Manager) assets, preventive maintenance schedules, work orders, and related documentation.
  5. Ensure the proper functioning of the Vaisala Environmental Monitoring System.
  6. Maintain and update facility schematics (P&IDs, floor plans, etc.).
  7. Assist in investigations and follow-up actions to address Deviations, CAPAs, and Change Controls.

Qualifications:

  1. Bachelor's degree in engineering or a life sciences discipline, with a minimum of three years of experience in a GMP manufacturing setting.
  2. Experience in coordinating maintenance activities and knowledge of maintenance principles within a regulated manufacturing environment.
  3. Prior experience in a cleanroom or GMP-compliant manufacturing facility.
  4. Strong organizational and communication skills.
  5. Ability to adapt to various tasks and prioritize effectively based on operational needs.
  6. Analytical and technical aptitude for troubleshooting equipment and instruments.
  7. Experience in maintaining facility and utility equipment in a GMP-regulated environment.
  8. Familiarity with GMP process and analytical equipment, including incubators, refrigerators, biological safety cabinets, small bioreactors, and centrifuges.
  9. Experience with CMMS platforms (e.g., Blue Mountain, SAP, Maximo) and managing maintenance documentation.
  10. Proficiency in AutoCAD for managing facility drawings is advantageous.
  11. Previous experience managing Deviations, Out of Tolerance (OOT) issues, CAPAs, and Change Controls within a Quality Management System (QMS) framework.
  12. Demonstrated ethics and integrity in professional conduct.


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