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Orca Bio

Posted 2 months ago

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Manager, Facilities

SacramentoOn-siteFull-time

AI Summary

Manages facility operations and maintenance for a GMP biopharma manufacturing site, ensuring safe, compliant facility systems and coordinating vendor services, calibration, and projects.

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.

The Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, coordinating and executing maintenance and calibration/certification activities, operating utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization, including managing facilities programs, services and activities.
This will be an onsite role at our clinical manufacturing facility (3400 Business Drive) with a schedule of Monday - Friday (7 a.m. / 8 a.m. to 4 p.m. / 5 p.m.).

Key Responsibilities:

Facility Operations & Maintenance:

  • Oversee the day-to-day operations and maintenance of the facility, ensuring all systems are functioning properly (HVAC, electrical, plumbing, security, etc.).

  • 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.

  • Manage vendor relationships for services such as cleaning, pest control, maintenance and calibration services, ensuring delivery of quality services and compliance with service agreements.

  • Review and approve vendor service documentation

  • Respond to facility-related requests, BMS and FMS alarms, and emergent issues

  • Complete quarterly trend reviews for alarm management and pest control programs.

    • 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 and space planning.

  • Manage projects related to the installation of new equipment.

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

    • Qualifications:

    Education:
  • Associate’s or Bachelor’s degree in Facility Management, Engineering, or a related field preferred.
    • Experience:
  • 5 years of experience in facility management in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical manufacturing facility.
    • Skills:

  • Strong knowledge of building systems (HVAC, electrical, plumbing), 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.

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

    • Working Conditions:

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

  • Gowning for cleanroom access.

    • Skills

    Alarm ManagementBiopharmaceutical FacilityBMS/FMS AlarmsCalibration ProgramsCleanroom GowningCMMSElectrical SystemsFacility MaintenanceGmp Regulatory StandardsHVACPest ControlPlumbingPMS/PMProject CoordinationRecord KeepingSafety ProgramsSpace PlanningVendor DocumentationVendor Management

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