Position Summary:

The Process Engineer at CARsgen Therapeutics' Durham facility is a technical role and it is a great opportunity to grow your career within Maintenance and Engineering areas supporting leading-edge CAR-T therapy manufacturing. The individual in this role must prioritize and coordinate the maintenance of process, facility, and analytical equipment at the GMP manufacturing facility. This individual must actively manage his/her schedule and external suppliers to reliably support facility/utility operations and production systems. Additionally, the selected individual must become proficient in the use of the computerized maintenance management system and manage the usage of the system for maintenance operations.

Responsibilities:

1. Coordinate maintenance activities with internal stakeholders and vendors within a GMP process facility.
2. Thoroughly review controlled documentation for clarity and traceability.
3. Assist in the development and maintenance of standard operating procedures (SOP) and equipment forms/logbooks for the department
4. Maintain CMMS (Blue Mountain Regulatory Asset Manager) assets, PM schedule, maintenance work orders and associated documentation.
5. Maintain Vaisala Environmental Monitoring System.
6. Maintain facility drawings (P&ID’s, Floorplans, etc.).
7. Assist with investigations and action items to support Deviations, CAPA’s, and Change Controls.

Qualifications:

1. Bachelor’s degree in engineering or life science related field and a minimum of three years of experience in a GMP manufacturing environment
2. Coordination experience and knowledge of maintenance principles within a manufacturing and GMP process facility.
3. Previous experience working in a cleanroom or GMP/regulated manufacturing environment.
4. Strong communication and organizational skills.
5. Flexibility to perform various tasks and ability to prioritize based on business needs.
6. Analytical and technical skills to work through and troubleshoot equipment and instruments.
7. Experience maintaining supportive facility & utility equipment in a GMP regulated facility.
8. Experience with GMP process and analytical equipment such as incubators, refrigerators and freezers, biological safety cabinets, small bioreactors, centrifuges.
9. Experience working with a CMMS (Blue Mountain, SAP, Maximo, etc) and managing maintenance work orders and associated documentation.
10. Experience working with AutoCAD for drawing management is a plus (preferred).
11. Previous experience handling Deviations, OOT, CAPAs, and Change Controls for equipment within a QMS framework.
12. Ethics and Integrity.