Head of Calibration & Maintenance, Bothell
Sana Biotechnology
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 the Head of Calibration & Maintenance, you will report to the Sr. Director of Facilities and Engineering, Site Start Up to launch maintenance and calibration programs for a new cGMP manufacturing facility. You will be at the forefront of delivering new capabilities for the organization by being a critical component in starting up Sana’s first manufacturing site. In this capacity, you will define the way Sana maintains facilities and equipment going forward as well as build new relationships with vendors, suppliers, contractors, and amazing colleagues.
This position will be located in Bothell, WA when the facility is complete.
What you’ll do
- Manage, coordinate, and perform both corrective and scheduled preventive maintenance on production, facility, and utility systems in a GMP environment (for example: HVAC, parts washer, autoclave, compressed air, bioreactors)
- Ownership and creation of documented GMP maintenance and calibration plans/procedures
- Maintain Calibration program holistically as compliant quality system
- Maintain Maintenance program holistically as a compliant quality system
- System owner for setup and operation of CMMS system (as a GMP validated system)
- Lead the scheduling of vendor Calibrations, and system/filter certifications
- Manage and perform troubleshooting and repair of mechanical and electronic technologies used throughout a cGMP biopharmaceutical facility and QC laboratories
- Ensures preventative maintenance tasks, instrument calibrations, and air handling equipment certifications are completed on schedule
- Ensure staff executes, documents, and closes work orders in a compliant and complete manner
- Represent calibration and maintenance programs as required during audits by health authorities
- Manage resources (internal or external) to perform Non-GMP maintenance (Lights, office temp, doors, HVAC, other hard vendor contracts)
- Determination of maintenances to be performed internally and externally
- Management of vendors to perform specific maintenance on equipment that cannot be maintained by internal resources. Oversee and accept documentation created by vendors
- Creation and management of MRO inventory of spare parts in maintenance shop and interface with supply chain for storage of MRO inventory in GMP warehouse
- Responsible for upkeep and stocking of maintenance shop as consistently ready to perform maintenance on cell and gene therapy manufacturing/support equipment
- Be an after-hours on-call support escalation pathway on an infrequent basis
- During capital projects and facility expansions, act as a field interface with general contractors, subcontractors, and other field service providers
- Assist in annual budgeting for maintenance, calibration, spare parts
- Lead planning and scheduling for annual shutdown. Lead role during annual plant maintenance shutdowns
- Maintain current state of training with cGMP SOPs
- Engage in strategic and purposeful discussions to ensure stakeholder alignment when executing maintenance and calibration activities
- Influence decision making on facilities and equipment within the purview of maintenance and calibration
- Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
- Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
- Drive curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance driven environment
- Innate ability to assess talent that will help grow the organization and add to Sana’s culture
What we’re looking for
- BA or MS plus 7 yrs or equivalent combination of education and work experience
- At least 3 years of experience using/setting up/owning CMMS systems in FDA-regulated industries.
- At least 5 years of experience performing maintenance and calibrations in a cGMP environment.
- Experience managing/interacting with maintenance/calibration vendors.
- Excellent verbal and written communication skills with understanding of cGMP documentation requirement
What will separate you from the crowd
- Experience in the construction phase of a facility’s lifecycle and experience working in a start up environment.
- Experience interacting with regulatory agencies to defend maintenance and calibration programs is a plus+.
What you should know
- The base pay range for this position at commencement of employment is expected to be between $125,000 and $150,000/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.