New · posted Oct 15
Lyell Immunopharma · Biotechnology
Specialist I or II, Quality Assurance, Engineer- Validation
- Bothell, WA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
The Quality Assurance Specialist I or II provides QA oversight for Facility, Equipment, Utility (FEU), and Computer System (CS) programs in a cell therapy manufacturing environment, with accountability for review, approval, escalation, and lifecycle compliance activities that support GMP readiness and sustained operational control.
This role serves as the Quality representative on cross-functional project teams and ensures Facility, Equipment, Utility, and Computer System activities are planned, executed, documented, and maintained in compliance with GMP requirements while supporting clinical and commercial operating timelines.
Facility, Equipment, and Utility Oversight
- Support onboarding of new Facility, Equipment, and Utility assets by approving initial release requirements and defining quality expectations for lifecycle management.
- Provide QA oversight for the calibration and maintenance programs to ensure ongoing GMP compliance and operational readiness.
- Review and approve work plans including procedure, test points, tolerances, and acceptance criteria.
- Review and approve asset removal, return-to-service activities, and associated quality documentation.
- Review and approve on-demand work orders for unplanned events and repairs.
Quality Systems
- Review and approve Standard Operating Procedures related to Facility, Equipment, Utility, and Computer System operation and maintenance.
- Review and approve change controls, deviations, and Corrective and Preventive Actions (CAPAs) related to Facility, Equipment, Utility , and Computer Systems.
What you need
REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in life sciences or a related technical discipline with a minimum of 5 years for Specialist I, or 8 years for Specialist II, experience in a GMP biopharmaceutical manufacturing environment or equivalent combination of relevant education, training, and experience.
Commissioning, Qualification, and Validation
- Provide QA compliance oversight for Facility, Equipment, Utility, and Computer System qualification and validation projects.
- Review and approve validation plans, User Requirement Specifications (URS), protocols (IQ/OQ/PQ), and summary reports for equipment and systems.
- Maintain oversight of the qualified and validated state of Facility, Equipment, Utility , and computer systems through periodic review, requalification, deviation review, and change management.
- Create and manage qualification and validation project schedules.
KNOWLEDGE SKILLS AND ABILITIES
- Understanding of requirements and expectations for compliant Facility, Equipment, and Utility programs including commissioning/qualification, calibration, and maintenance.
- Ability to work effectively both independently and cross-functionally.
- Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
- Excellent communication, emotional intelligence and interpersonal skills.
- Familiar with quality management systems (e.g. deviations, CAPAs, change management).
- Curious and proactive mindset with a continuous improvement orientation.
PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
- Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.
PREFERRED EXPERIENCEnice to have
- Prior experience in a Quality Assurance oversight role for Facility, Equipment, and Utility qualification and management.
- Experience with computer system validation.
- Previous experience using Blue Mountain computerized maintenance management software.
- Experience with cell therapy and/or lentiviral manufacturing operations.
- Experience in commercial manufacturing and post-approval lifecycle management.
Skills named in this posting
Pay and benefits
$130,000 – $150,000 a year
Employer providedThe salary range for this position is $130,000 to $150,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
Annual bonus opportunity
Equity Incentive Plan
Where you'll work
Bothell, WAOn-siteOpen in Maps (opens in a new tab)
More jobs in Bothell, WASchedule and working conditions
Days
SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE
While this position is primarily Monday – Friday, occasional off-shift work, weekend work, and holiday work may be required due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible.
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.
Equal opportunity, accessibility and legal noticesLyell Immunopharma's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 78% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in Washington6 roles publishing pay
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $130,000 | — | $150,000 |
| Washington (middle half) | $73,000 | $88,500 | $109,250 |
| All US (middle half) | $59,000 | $78,500 | $94,000 |
This role: Lyell Immunopharma's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Lyell Immunopharma's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems8
- Validation and qualification7
- GMP and compliance5
- Documentation and SOPs4
- Collaboration and leadership4
- Investigations and CAPA3
- Quality systems and risk3
- Lab testing and methods1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Lyell Immunopharma on Regulatory Jobs
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- Open roles
- 2
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- Locations
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Specialist I or II, Quality Assurance, Engineer- Validation at Lyell Immunopharma
Open until filled. $130K–$150K a year, employer provided.