Facilities Engineer II
5 days ago
Job Summary:
CARsgen Therapeutics is seeking a skilled Facilities Engineer II to join our team in Durham. As a key member of our Maintenance and Engineering department, you will play a critical role in ensuring the smooth operation of our GMP manufacturing facility.
Key Responsibilities:
- Coordinate maintenance activities with internal stakeholders and vendors to ensure seamless facility operations.
- Review and maintain controlled documentation to ensure clarity and traceability.
- Develop and maintain standard operating procedures (SOPs) and equipment forms/logbooks for the department.
- Manage the Computerized Maintenance Management System (CMMS) assets, PM schedule, maintenance work orders, and associated documentation.
- Maintain the Vaisala Environmental Monitoring System and facility drawings (P&IDs, floor plans, etc.).
- Assist with investigations and action items to support Deviations, CAPAs, and Change Controls.
Requirements:
- Bachelor's degree in engineering or a life science-related field and a minimum of three years of experience in a GMP manufacturing environment.
- Coordination experience and knowledge of 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 (Blue Mountain, SAP, Maximo, etc.) and managing maintenance work orders and associated documentation.
- Experience working with AutoCAD for drawing management is a plus (preferred).
- Previous experience handling Deviations, OOT, CAPAs, and Change Controls for equipment within a QMS framework.
- Ethics and Integrity.
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