Sr Quality Engineer I (Computer System Validation)

Location: El Segundo, California, United States; onsite

Salary: $123,930–$160,380 per year, plus potential annual bonus, long-term stock-based incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and T-cell receptor engineered cell therapies.

What you will do

• Provide quality engineering oversight for validated computer systems, ensuring compliance with cGMP, regulatory requirements, lifecycle procedures, data integrity, and intended use.
• Lead and support enterprise, cross-functional, and site computer system validation activities, including validation strategies, methodologies, deliverables, and quality oversight.
• Review and approve validation plans, requirements, specifications, test cases, protocols, traceability matrices, validation reports, SOPs, and related documentation.
• Assess proposed changes to validated systems, determine validation requirements, and oversee compliant change control and impact assessments.
• Support validation and deployment of manufacturing and laboratory systems, including automation and integration with enterprise systems.
• Identify and communicate compliance, technical, and process risks; support audits and inspections and drive corrective actions through closure.

Requirements

• Master’s degree plus 4+ years, bachelor’s degree plus 6+ years, associate degree plus 8+ years, or high school diploma/GED plus 10+ years of relevant computer systems validation experience in a cGMP environment.
• 6+ years of experience in an FDA-regulated environment and in software quality assurance and/or computer system validation.
• Strong knowledge of cGMP, 21 CFR Part 11, Annex 11, data integrity, and validation lifecycle requirements.
• Experience reviewing qualification protocols and validation documentation, including resolving non-conformances and deviations.
• Strong critical thinking, risk-based decision-making, ownership, communication, and cross-functional collaboration skills.
• Proficiency with Microsoft Office and comfort working in a fast-paced, evolving environment.

Culture & Benefits

• Work in a multidisciplinary environment focused on developing cancer therapies.
• Collaborate across site, network, Quality, manufacturing, laboratory, and project teams.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• Eligible employees may receive paid time off, a discretionary annual bonus, and discretionary stock-based long-term incentives.
• Inclusive workplace committed to equal employment opportunity and diverse perspectives.