Specialist, Quality Assurance Validation
Lyell Immunopharma
June 25, 2026
On-site
Bothell, WA
Operations
Quality Assurance Specialist
Responsibilities:
- Provide QA compliance oversight for Facility, Equipment, Utility (FEU) and Computer System (CS) qualification/validation projects.
- Review and approve validation plans, URS, IQ/OQ/PQ protocols, and summary reports.
- Maintain oversight of qualified/validated state via periodic review, requalification, deviation review, and change management.
- Create and manage qualification/validation project schedules.
- Support onboarding of new FEU assets (initial release requirements; lifecycle quality expectations).
- Oversee calibration and maintenance programs for ongoing GMP compliance.
- Review/approve work plans (procedures, test points, tolerances, acceptance criteria).
- Review/approve asset removal and return-to-service activities and documentation.
- Review/approve on-demand work orders for unplanned events/repairs.
- Review/approve SOPs for FEU/CS operation and maintenance.
- Review/approve change controls, deviations, and CAPAs related to FEU/CS.
Qualifications & Experience:
- Bachelor’s degree in life sciences or related technical discipline.
- Minimum 5 years’ experience in a GMP biopharmaceutical manufacturing environment (or equivalent education/training/experience).
Preferred:
- QA oversight for FEU qualification/management.
- Computer system validation experience.
- Blue Mountain computerized maintenance management software.
- Cell therapy and/or lentiviral manufacturing experience.
- Commercial manufacturing and post-approval lifecycle management.
Skills:
- GMP FEU program knowledge (commissioning/qualification, calibration, maintenance).
- Work independently and cross-functionally.
- Fast learner; adaptable in a fast-paced start-up environment.
- Strong communication and interpersonal skills.
- Familiar with deviations, CAPAs, and change management; continuous improvement mindset.
Benefits/Pay:
- $96,000–$120,000 annual salary; annual bonus opportunity; eligibility for Lyell’s Equity Incentive Plan.
Application:
- If you’re interested and think you could fit, apply.
Responsibilities:
- Provide QA compliance oversight for Facility, Equipment, Utility (FEU) and Computer System (CS) qualification/validation projects.
- Review and approve validation plans, URS, IQ/OQ/PQ protocols, and summary reports.
- Maintain oversight of qualified/validated state via periodic review, requalification, deviation review, and change management.
- Create and manage qualification/validation project schedules.
- Support onboarding of new FEU assets (initial release requirements; lifecycle quality expectations).
- Oversee calibration and maintenance programs for ongoing GMP compliance.
- Review/approve work plans (procedures, test points, tolerances, acceptance criteria).
- Review/approve asset removal and return-to-service activities and documentation.
- Review/approve on-demand work orders for unplanned events/repairs.
- Review/approve SOPs for FEU/CS operation and maintenance.
- Review/approve change controls, deviations, and CAPAs related to FEU/CS.
Qualifications & Experience:
- Bachelor’s degree in life sciences or related technical discipline.
- Minimum 5 years’ experience in a GMP biopharmaceutical manufacturing environment (or equivalent education/training/experience).
Preferred:
- QA oversight for FEU qualification/management.
- Computer system validation experience.
- Blue Mountain computerized maintenance management software.
- Cell therapy and/or lentiviral manufacturing experience.
- Commercial manufacturing and post-approval lifecycle management.
Skills:
- GMP FEU program knowledge (commissioning/qualification, calibration, maintenance).
- Work independently and cross-functionally.
- Fast learner; adaptable in a fast-paced start-up environment.
- Strong communication and interpersonal skills.
- Familiar with deviations, CAPAs, and change management; continuous improvement mindset.
Benefits/Pay:
- $96,000–$120,000 annual salary; annual bonus opportunity; eligibility for Lyell’s Equity Incentive Plan.
Application:
- If you’re interested and think you could fit, apply.