Senior Facilities Project Engineer
Sana Biotechnology
About the role
Sana Bio is seeking a motivated and innovative Sr. Facilities Project Engineer to serve in the Facilities and Engineering department. As part of the F&E group, you will have opportunities to work on and take ownership of a wide range of projects from system and workflow implementation, to facility and lab capital buildouts, troubleshooting and investigations, maintenance and calibration program creation. Sana Bio is currently expanding its capabilities through construction of a GMP manufacturing facility and QC testing laboratory in Bothell, WA. As Sr. Facilities Project Engineer, you will report to the Sr. Director of Facilities and Engineering Site Start up. As part of F&E, you will have an opportunity to make and influence decisions on the ground floor for how we deliver GMP facilities as we grow the organization and expand capabilities to meet project goals that ultimately improve patient outcomes.
What you’ll do
- Creation and ownership of User Requirements Specifications for facilities/utilities systems.
- Facilitate delivery/construction of GMP compliant facility under GEP and quality change management
- Ensure construction and other aspects of facility delivery satisfies design intent, Basis of Design, and construction drawing sets
- Responsible for setup and implementation of facilities equipment to support future GMP operations
- Sustain process, analytical, and facilities equipment after construction. Executes future (e.g. continuous improvement or NPI) changes to validated equipment under GMP compliance
- Follow GxP principles in troubleshooting equipment issues and ensures equipment is satisfying user (manufacturing or QC) requirements
- Technical lead and primary point of contact between Sana and construction contractors, architectural, and engineering firms for process scope. Engages process SMEs as required. Field RFIs, submittals, and other official communications on behalf of Sana
- Main technical interface with Validation Manager when VM is creating and executing qualifications for facilities/utilities
- Provide input to and information for RFP and other procurement activities for engineering, construction, and facilities service contracts such as pest control and GMP cleaning
- Create procedures and processes for operation of facilities/utilities and interfaces with automation systems (BMS, EMS, Historian, etc)
- Lead creation of protocols and execution of Commissioning, SAT, FAT for systems which require such start up activities
- Executes GMP asset management and acts as system owner, defines maintenance needs, calibrations, and critical spares for facility/utility systems
- Oversees equipment as system owner and aligns with maintenance department during annual shutdowns
- Ownership of Turnover Packages for all facility/utility systems
- Initiate, assess, and own change controls, CAPA’s, and deviations in Sana’s Quality Management System
What we’re looking for
- At least 7 years experience performing the duties of a Process, Utilities, or Facilities Engineer
- Bachelors degree or higher in engineering or related field
- Experience in delivering new facilities and transitioning a facility from construction to an operating part of its lifecycle
- Experience using CMMS systems in cGMP facilities
- Experience managing facility systems and being system owner in cGMP environment
- Clear verbal and written communicator with demonstrated skills producing documents of GDP completeness
What will separate you from the crowd
- Experience in delivering new facilities and transitioning a facility from construction to an operating part of its lifecycle
- Experience interacting with regulatory agencies on the topics of facilities and utilities systems is a plus
What you need to know
- 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.