Sr Quality Engineer I

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Sr. Quality Engineer I  

We are seeking a highly motivated individual to join us as Sr. Quality Engineer I at our El Segundo location. The ideal candidate will build strong partnerships across the site and network organizations and thrive in an environment that values teamwork, change agility, risk-based decision making, and flexibility. This role is expected to make a significant contribution to a multi-disciplinary team and requires strong written and verbal communication skills, sound quality judgment, and a high degree of personal ownership. 

The Sr. Quality Engineer I provides Quality Engineering oversight of site processes related to validated computer systems, including Computer System Configuration Management and Computer System Validation (CSV), ensuring compliance with regulatory requirements, lifecycle procedures, and Data Integrity expectations. This position supports and leads CSV activities at the El Segundo location, reviews and approves validation documentation and risk assessments, works with project teams to determine which elements require validation, and conducts impact assessments for proposed changes to computerized systems. 

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. 

Responsibilities: 

• 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. 

• Provide quality oversight for change control activities related to validated computer systems, ensuring technical and quality impact assessments are performed in a compliant manner and systems remain in a validated state. 

• Support risk-based validation of enterprise and site computer systems. 

• Identify, pressure-test, and clearly communicate compliance, technical, and process risks early, escalating as needed to support timely decision making and effective risk mitigation. 

• Participate as the quality engineering representative in project team activities and computer system design discussions to ensure cGMP compliance and cross-site consistency. 

• Clearly articulate quality rationale, validation expectations, and risk-based recommendations to cross-functional stakeholders. 

• Support CSV projects across manufacturing and laboratory systems, including operational change management activities associated with those systems and applications. 

• Support implementation and deployment of manufacturing automation systems, including integration with enterprise and supporting systems. 

• Support new computer system introduction by serving as a technical resource and providing validation and quality expertise. 

• Apply critical thinking and sound quality judgment when evaluating ambiguous, complex, or non-routine situations. 

• Drive actions and commitments through closure with proactive communication of status, risks, and support needs. 

• Drive continuous improvement and innovation in computer system validation and related quality processes. 

• Support regulatory inspections and audits. 

• Communicate effectively at all levels within Quality and cross-functional across departments and sites. 

• Perform other duties as assigned. 

Basic 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

OR 

• Associate degree and 8+ years of relevant computer systems validation experience in a cGMP environment

OR 

• High school diploma / GED and 10+ years of relevant computer systems validation experience in a cGMP environment 

Preferred Qualifications: 

• 6+ years of experience in an FDA-regulated environment with a strong understanding of cGMP requirements and risk-based validation principles. 

• 6+ years of experience in software quality assurance and/or computer system validation. 

• 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. 

• Ability 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. 

• Ability to communicate proactively and effectively when facing challenges, competing priorities, or uncertainty. 

• Excellent interpersonal, verbal, and written communication skills in a collaborative cross-functional environment. 

• Proficiency with Microsoft Office applications. 

• Comfortable operating in a fast-paced and evolving environment.