Hiring: Sr Quality Engineer I Company: Kite Pharma Location: El Segundo, CA Job Posted Time: 2026-09-12 11:39:58 Target Skills & Keywords : Change Management, Configuration Management, Microsoft Office, Quality Assurance, Systems Design, Workday About the job Experience: •4+ years of relevant computer systems validation experience in a cGMP environment •6+ years of relevant computer systems validation experience in a cGMP environment •8+ years of relevant computer systems validation experience in a cGMP environment •10+ years of relevant computer systems validation experience in a cGMP environment •6+ years of experience in an FDA-regulated environment with a strong understanding of cGMP requirements and risk-based validation principles. Required Skills: •Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in this mission! •We are seeking a highly motivated individual to join us as Sr. •This role is expected to apply a quality-first mindset and make sound, risk-based decisions supported by clear quality and compliance rationale. The position ensures compliance with Kite procedures and all applicable regulatory requirements. •Provide Quality Engineering oversight for validated computer systems, ensuring compliance with cGMP, applicable regulatory requirements, lifecycle procedures, Data Integrity expectations, and intended use requirements. •Lead and support enterprise, cross-functional, and local computer system validation activities by providing validation approach, methodology, deliverables, and quality oversight. •Review and approve validation lifecycle documentation, including Validation Plans, UAT plans, requirements and specifications, SOPs, test cases, protocols, Traceability Matrices, and Validation Summary Reports, in partnership with functional teams to ensure compliance and quality standards are met. •Independently assess validation lifecycle deliverables, change records, and supporting documentation for accuracy, completeness, internal consistency, and readiness for approval. •Evaluate proposed changes to validated computer systems and recommend the appropriate level of validation required for proposed changes. Qualifications: •Master’s degree and 4+ years of relevant computer systems validation experience in a cGMP environment •OR Bachelor’s degree and 6+ years of relevant computer systems validation experience in a cGMP environment •Associate degree and 8+ years of relevant computer systems validation experience in a cGMP environment •High school diploma / GED and 10+ years of relevant computer systems validation experience in a cGMP environment •Strong working knowledge of cGMP, 21 CFR Part 11, Annex 11, Data Integrity, and validation lifecycle requirements. •Proven ability to review qualification protocols and associated validation lifecycle documentation, including identification and resolution of non-conformances and deviations. •Demonstrated ability to apply critical thinking and problem-solving skills in complex or ambiguous situations. •Demonstrated capacity to make sound, risk-based decisions and clearly document or explain the supporting quality rationale. •Strong sense of ownership and accountability for deliverables, approvals, and follow-through. •Demonstrated capacity to communicate proactively and effectively when facing challenges, competing priorities, or uncertainty. Compensation: •$123,930 - $160,380 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!