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Senior Instrumentation Calibration Technician

Sana Biotechnology

Sana Biotechnology

Bothell, WA, USA
Posted on Thursday, November 9, 2023

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, and cleanroom environments
  • The role will be located in Seattle, WA until the Bothell manufacturing site is ready for occupancy
  • The base pay range for this position at commencement of employment is expected to be between $96,000 and $115,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together

  • Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
  • Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
  • Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’s Benefits Portal.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.