About the role

Sana Biotechnology manufacturing facility in Bothell, WA, is hiring new team members who believe in the potential of engineered cells as medicines, dedicated to quality, and passionate about delivering the possible to patients. 

As a CMMS Senior Planner-Scheduler, you will report to the Associate Director, Calibration and Maintenance in the Facilities and Engineering department of Sana’s Bothell GMP manufacturing facility. In this role, you will be at the ground floor of defining the site’s asset management practices, and best utilization of the site’s CMMS as a GMP compliant system. You will have the opportunity to implement and improve the site’s CMMS and associated processes, develop/implement work plans/data sheets in the CMMS, and plan/schedule recurring work, on-demand work, and project-based work. As the CMMS Senior Planner-Scheduler, you will work collaboratively with the calibration and maintenance team, outside contractors, and internal stakeholders to provide best-in-class service in support of our mission. This role is required to be onsite in Bothell, WA.

What you’ll do

• Lead setup and operation of CMMS system (as a GMP validated system) for all maintained assets at the site
• Act as the site’s CMMS administrator to maintain all applicable data in the CMMS, such as asset records, maintenance work plans, calibration data sheets, and events/schedules
• Create, maintain, and oversee data in the CMMS to ensure all data is accurate, consistent, and in alignment with applicable procedures, or best asset management practices
• Coordinate/schedule maintenance, calibration, and repair events with end user groups (e.g. manufacturing, quality control) to ensure minimal impact to operations
• Work directly with technicians when creating work plans, and periodically supervise maintenance activities to identify continuous improvement opportunities
• Monitor work requests, generate work records, and plan/schedule/assign work records to technicians.
• Provide oversight of the CMMS to monitor schedule adherence and provide notification to the necessary groups for overdue work records
• Generation of reports and metrics to monitor the health and performance of the site’s asset management/maintenance processes
• Scheduling of external service providers, as necessary, in support of both routine work events and repairs
• During capital projects and facility expansions, act as a field interface with general contractors, subcontractors, and other field service providers, as required
• Lead planning and scheduling for periodic facility shutdowns
• Initiate, assess, and own change controls, CAPA’s, and deviations in Sana’s Quality Management System
• Optimization of work schedules in the CMMS to maximize scheduling efficiencies, while ensuring work is load-levelled appropriately to support staffing and production needs
• Work directly with external service providers ensure that SOWs, as necessary, accurately reflect the needs of the maintenance/calibration requirements of the site’s assets
• Administration and management of maintenance and calibration service contracts
• Perform job tasks in compliance with all applicable GMP and safety requirement
• Assist with managing and adhering to the established operations budget
• Assist with managing the spare parts inventory (MRO), such as sourcing parts, determining stock to keep on hand, ordering, and receiving parts
• Represent F&E as a Subject Matter Expert (SME) on asset and maintenance management during regulatory inspections
• Maintain current state of training with cGMP SOPs
• Performs other related duties as assigned by Facilities and Engineering Management

What we’re looking for

• Required: High School Diploma
• Preferred: 2-year technical degree or higher in maintenance, automation, or related discipline
• Strong working knowledge in the operation and maintenance of the following utilities/systems: HVAC, clean compressed air generation and delivery, water systems, and emergency power generators and electrical systems
• 5-7 years’ experience operating/administering a CMMS system in a cGMP environment.
• Demonstrated ability to effectively plan and schedule maintenance and calibration activities while minimizing impact to operations
• Strong foundational knowledge in the subject of asset management, maintenance strategies, and how to apply them in a CMMS
• Ability to manage competing priorities while delivering a high level of service
• Excellent verbal and written communication skills, with an emphasis on technical writing acumen
  
  

What will separate you from the crowd

• Experience in starting up a GMP facility and transitioning a facility from construction to the operating phase of its lifecycle
• Experience setting up a CMMS system from the ground-up
• Experience as a CMMS administrator at a GMP manufacturing facility
• Experience with developing and improving maintenance and calibration programs in a GMP environment
• Direct experience interacting with regulatory agencies (e.g. FDA, EMEA) during inspections

What you should know

• Measurement Skills: Basic understanding of measurements, calculations, and the metric system
• Language Skills: Must be able to communicate effectively in English. Examples of English language proficiency may include (but are not limited to): ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals; ability to write routine reports, maintenance instructions, and correspondence; ability to verbally communicate with leadership, employees, and auditors; ability to comprehend spoken language
• Physical Demands: Employees in this position may be required to perform the following physical activities: standing, walking, and sitting for extended periods of time; frequent use of the hands, fingers, wrist, and greater arm to handle small materials, tools, boxes, and trays; lifting and carrying objects up to 50Ibs; occasional overhead reaches and lifts; occasional lifts and reaches below the knee; occasional pushing and pulling of materials and objects with moderate forces; occasional crouching/kneeling, twisting, and squatting movements
• Work Environment: Employees may be exposed to the following environmental conditions while performing this job: work near moving parts, work with chemicals, outdoor weather conditions, exposure to intense light and/or intermittent light, fast-paced work, and elevated noise levels
• This position will require work to be performed in utility/mechanical spaces, compressed gas delivery/storage areas, electrical/server rooms. and cleanroom environments
• The base pay range for this position at commencement of employment is expected to be between $105,000 and $125,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience