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10.11.21
Bothell, Washington, United States
Senior Engineer
Manufacturing
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.
 
POSITION SUMMARY:
The incumbent is responsible for supporting the utility operations of our manufacturing facility.  This role will be responsible for developing, implementing, and maintaining a strategic approach to maintenance and operational reliability for all site assets. The incumbent will be an subject matter expert in critical engineering disciplines (Process, Electrical, Instrumentation, Mechanical, HVAC). 

KEY ROLE AND RESPONSIBILITIES:

  • Capital Project Support
    • Provide engineering and project management to capex projects, including direction of other technical and contract personnel.
    • Support new product/process/technology introductions by performing facilities & engineering assessments and implementing facilities and utility system modifications as necessary.
    • Ensure systems are installed and operating safely, and align with pertinent environmental health and safety practices, rules, and regulations.
  • Utility & Facility GMP Operations
    • Act as system owner of mechanical systems and utilities at the site.
    • Provide engineering expertise and support to Manufacturing, Quality, and Facility Services on a variety of HVACR systems (clean rooms, chillers, heat recovery, hydronic distribution, heating hot water, air handlers, filtration, distribution and cold rooms/freezers/refrigeration).
    • Identify, analyze, and design improvements and capabilities for facility, utility, process, and equipment systems.
    • Develop and maintain engineering documentation such as O&M, Asset documentation, P&IDs, design drawings and specifications.
    • Collaborate in continuous improvement of technical infrastructure including standards, practices, specifications, procedures, and business processes.
    • Responsible for building utilities operation and maintenance activities.
    • Ensure optimal and cost-effective performance and reliability of facilities and utility systems.
    • Resolve GMP facility equipment/systems issues such as HVAC, boilers, chillers, cooling towers, compressed air/medical gasses, freezers/cold rooms, fire protection, fire alarm, electrical systems/motor controls, building automation, laboratory equipment/laboratory gases, cryo-gases, architectural/roofing systems, and underground piping/utilities.
    • Monitor systems to identify performance risks and implement risk reduction strategies.
    • Provide technical problem-solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
    • Manage Deviations/CAPAs within the facilities & engineering team to ensure appropriate actions are identified that address the root causes as well as on-time closure of the records
    • Manage facility and engineering Change control initiatives.
  • E-System administration
    • Provide administrative function and operational expertise for:
      • Computerized maintenance management software (CMMS)
      • Equipment monitoring system (EMS).
    • Building Management System
    • Other systems as assigned

PREFERRED EDUCATION:

  • High School Diploma or equivalent required, preferably including hands-on or vocational school training; or
  • Associate degree in Mechanical/Utilities Technology, or Licensed Journeyman. 
  • Technical or Maintenance Certifications/Licenses (CMRT, FMC, HVAC/R license)

 PREFERRED EXPERIENCE:

  • 10+ years of experience in facilities & engineering in a GMP manufacturing environment for the biopharmaceutical industry, experience in cell and gene therapy is a plus.
  • Experience with a CMMS, preferably Blue Mountain RAM.
  • Experience in commissioning facilities and utility systems.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Expert mechanical acumen including HVAC, facilities utilities, P&ID's, schematics and equipment specifications is a must.
  • Demonstrated understanding of systems needed to operate a GMP facility such as those for HVAC, electrical, compressed gas systems, plumbing/piping, general maintenance, and interior and exterior pest management.
  • Demonstrated proficiency in current Good Manufacturing Practices (GMPs).
  • Understanding of safety requirements for working in a GMP biopharmaceutical manufacturing facility.
  • Exposure to operations involving engineering disciplines including Electrical, Mechanical, Process, Structural, Environmental, and Industrial.
  • Independent, self-motivated, organized, and able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
  • Great teammate and embraces a team-based culture that relies on collaboration for effective decision-making.
  • Work schedule flexibility as required to support 24/7/365 operations, requiring occasional after-hours coverage.
  • Forward thinking and the ability to work with system metrics to identify deficiencies and improving programs and performance.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
 
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.
 
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