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Orca Bio

Posted 3 months ago

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Senior Facility Manager

SacramentoOn-site

AI Summary

The Senior Facility Manager oversees daily operations and maintenance of a large-scale cell therapy manufacturing facility, ensuring systems reliability, GMP compliance, and coordination with service providers and landlords.

About this 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 late-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 investigational 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.

The Senior Facility Manager is responsible for overseeing and maintaining the physical tenant infrastructure, operating and maintaining all utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. The Senior Facility Manager works closely with other departments to support the overall goals of the organization.

Physical Demands

  • 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.

    • Work Conditions

  • 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.

    • Facility Operations & Maintenance:

  • Oversee the day-to-day operations and maintenance of the facility, ensuring all systems are functioning properly (HVAC, chilled water, heating hot water, clean dry air, electrical distribution, emergency generator, uninterruptible power, RODI water, domestic water systems, etc)

  • Manage service provider relationships (cleaning, pest control, security, maintenance and technical support services, etc.), ensuring delivery of quality services and compliance with service agreements.

  • Develop, implement and manage preventive maintenance and calibration programs to ensure the facility is GMP compliant.

  • Collaborate with Facilities and Production Planning to schedule and coordinate repairs and maintenance activities for building systems and equipment.

  • Ensure accurate record-keeping for facility operations, and equipment maintenance, including Computerize Maintenance Management System (CMMS) and logbooks.

  • Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures

  • Track and report on system/equipment downtime, failure trends and develop corrective actions to prevent recurrence

  • Coordination and execution of onsite and preventative and corrective maintenance, calibration and certification activities completed by service providers

  • Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS

    • Health, Safety & Compliance:

  • Ensure the facility complies with all relevant safety, environmental, and regulatory requirements (e.g., OSHA, GMP, FDA, local building codes).

  • Participate in regular inspections to identify and mitigate risks related to safety, health, and environmental impacts.

    • Budget Management:

  • Support development and management of the facility’s operational and maintenance budget, controlling costs related to maintenance, repairs and outside services.

    • Project Management:

  • Plan and coordinate facility-related projects such as improvements or expansions.

  • Manage projects related to the installation of new equipment.

  • Work with other departments and external contractors and vendors to ensure successful project execution.

    • Education:

  • Bachelor’s degree in Facility Management, Engineering, or related field preferred, or equivalent job experience.

    • Experience:

  • 7-10 years of experience in facility operations and management in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical industry.

    • Skills:

  • Strong knowledge of building systems operations (HVAC, RODI, compressed air, domestic water, electrical), maintenance and calibration programs, GMP regulatory standards, and safety requirements in the biopharmaceutical/cell therapy industry.

  • Excellent leadership, communication, and interpersonal skills.

  • Experience/proficiency with maintenance management software and systems.

  • Excellent project and time management skills with the ability to oversee multiple tasks at once.

  • Budgeting experience.

  • Problem-solving and troubleshooting, and ability to make sound decisions.

    • Working Conditions:

  • The position requires on-site presence and regular work hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response.

    • Skills

    CalibrationCertificationCMMSCompressed AirDomestic Water SystemsElectrical DistributionEmergency GeneratorFDAGMPHVACOSHAPreventive MaintenanceRODI Water SystemsUPS

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