Specialist, Facilities

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.

This Specialist, Facilities is responsible for facilities, utilities and production and laboratory assets across multiple production sites producing clinical and commercial drug products. This role involves providing technical expertise for asset operation and troubleshooting, and utilization of a Computerized Maintenance Management System (CMMS) to manage asset data, asset labelling, asset status, and to coordinate and execute preventative and corrective maintenance, calibration and certification activities to ensure compliant and reliable operations to support production requirements to meet customer needs.

They will also be responsible for managing and executing various projects in support of facility and utility system operations.

• Production Associate Roles:
  Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

• Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

• 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

• 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.

• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
• Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
• Willing to support sites after-hours on an as needed or on-call basis
• Strong interpersonal skills and ability to communicate…