active · Approximate location
Specialist, Facilities
full timeSacramento, CA
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AT A GLANCE
Operations4+ years experienceFull TimeRegular, Full-Time Employee
Required
- 4+ years experience
- People Leadership
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is
About the role
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
Responsibilities
- Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures
- Track and report on equipment downtime, failure trends and develop corrective actions to prevent recurrence
- Planning, scheduling and coordinating onsite and offsite preventative and corrective maintenance, calibration and certification activities to be completed by service providers
- Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS
- Ensure that facilities, utilities, production and laboratory assets are maintained, calibrated, and certified to applicable GMP standards
- Collaboration with peers in the continuous improvement of equipment standards, practices, specifications, procedures, qualifications and business processes
- Lead and/or participate in the identification and development of solutions to stabilize and optimize equipment systems
- Execution of facility preventative and corrective maintenance tasks, small projects and continuous improvements
- Onboarding new assets and maintaining current assets in the CMMS, including asset identification and status, labelling, and assigning required maintenance, calibration and certification plans
- Other duties as assigned
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Facility Management or equivalent technical experience
- 4 years of experience in GMP manufacturing facility, including equipment operation and troubleshooting, and facilities and asset maintenance execution in a GMP manufacturing facility
- Experience in analyzing, managing, and reporting reliability metrics, and managing assets and maintenance activities using a CMMS system
- Experience coordinating onsite and offsite maintenance, calibration and certification activities completed by service providers
- Experience in managing and executing facility and utility projects including repairs, improvements and new installations.
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