Quality Assurance Validation Specialist

Responsibilities

• Provide QA compliance oversight for Facility, Equipment, Utility, and Computer System qualification and validation projects
• Review and approve validation plans, URS, protocols (IQ/OQ/PQ), and summary reports
• Maintain oversight of the qualified and validated state through periodic review, requalification, and change management
• Support onboarding of new assets by approving initial release requirements
• Provide QA oversight for calibration and maintenance programs
• Review and approve SOPs, change controls, deviations, and CAPAs related to FEU and Computer Systems

Requirements

• Bachelor’s degree in life sciences or a related technical discipline
• Minimum of 5 years of experience in a GMP biopharmaceutical manufacturing environment
• Understanding of commissioning, qualification, calibration, and maintenance programs
• Familiarity with quality management systems (deviations, CAPAs, change management)
• Ability to stand and step over a gowning bench and aseptically don sterile gowns

Preferred Qualifications

• Prior QA oversight experience for Facility, Equipment, and Utility management
• Experience with computer system validation
• Experience using Blue Mountain CMMS software
• Experience with cell therapy or lentiviral manufacturing operations
• Experience in commercial manufacturing and post-approval lifecycle management

About the Company

Lyell is a biopharmaceutical company focused on developing life-saving autologous cell therapies.