Senior Instrumentation Calibration Technician

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas.  As a Sr. Instrumentation/Calibration Technician you will report to the Associate Director of 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 developing the GMP calibration program at Sana.  You will have the opportunity to build the calibration program, develop calibration practices and procedures, design and implement the site’s CMMS, manage calibration vendors/contracts (as necessary), identify critical spare parts, and work collaboratively with our customer groups to provide best-in-class service in support of our mission.

What you’ll do

• Calibrate, maintain, troubleshoot, and repair GMP manufacturing and laboratory equipment/instrumentation such as such as incubators, pressure gauges, temperature sensors, life safety gas detection monitoring equipment, controlled temperature storage equipment, and analytical lab equipment
• Execute corrective and scheduled calibration work orders on production, laboratory, facility, and utility systems in a GMP environment (such as HVAC, RODI water, autoclave, clean compressed air/CO2/N2 systems, liquid nitrogen [LN2] distribution systems, bioreactor systems, etc.) in a compliant and complete manner
• Assist in setup and operation of CMMS system (as a GMP validated system) for all calibrated/maintained assets at the site
• Maintain applicable data in the CMMS, such as asset records, calibration data, and events/schedules.
• Coordinate/schedule calibrations with end user groups (e.g. manufacturing, quality control) to ensure minimal impact to operations
• Oversee and manage calibrations performed by vendors, including reviewal of all service/calibration reports for accuracy and to ensure compliance with Sana’s requirements
• Maintain calibration program and CMMS as compliant quality system
• Provide input on the selection of calibration standards, calibration methodology, and test points/tolerances/intervals to align with industry best practices and any relevant guidance
• Provide after-hours on-call support, in rare instances, due to failure of equipment/instrumentation
• Execute, document, and close work orders in a compliant and complete manner
• Assist with managing the spare parts inventory (MRO), such as sourcing parts, determining stock to keep on hand, ordering, and receiving parts
• Upkeep and stocking of maintenance/calibration shop as consistently ready to perform cGMP calibrations on cell and gene therapy manufacturing and analytical instruments
• Assist with managing and adhering to the established operations budget
• Utilize the site’s Building Management System (BMS) and Equipment Monitoring System (EMS) to monitor, troubleshoot, and calibrate instrumentation on equipment and utilities
• Provide training to internal and external resources, as necessary, to ensure personnel are qualified to perform calibrations
• Ensure compliance with all applicable GMP and safety requirements while performing tasks
• Initiate, assess, and own change controls, CAPA’s, and deviations in Sana’s Quality Management System
• Represent F&E as a Subject Matter Expert (SME) during regulatory inspections
• Maintain current state of training with cGMP SOPs

What we’re looking for

• Required: High School Diploma
• Preferred: 2-year technical degree or higher in instrumentation, automation, or related discipline
• 5-7 years’ experience performing calibrations in a cGMP environment
• Experience using/setting up CMMS systems in FDA-regulated industries
• Experience managing/interacting with calibration vendors
• Ability to manage competing priorities while delivering a high level of service
• Excellent verbal and written communication skills with demonstrated comprehension of need to clearly document GMP calibration activities

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 with developing and improving calibration programs in a GMP environment
• Direct experience interacting with regulatory agencies (e.g. FDA, EMEA) during inspections

What you should know

• Ability to lift a minimum of 50 lbs.
• This position will require work to be performed in utility/mechanical spaces, compressed gas delivery/storage areas, electrical/server rooms