Senior / Staff Data Integrity Engineer (GxP)

Location: Hybrid in Sunnyvale, California, United States

Company

hirify.global operates in a regulated life sciences environment focused on data integrity, product quality, regulatory compliance, and patient safety.

What you will do

• Support the implementation and execution of the Data Integrity Program.
• Serve as the organization-wide Data Integrity Subject Matter Expert across the data life cycle.
• Perform quarterly Data Integrity reviews and prepare reporting.
• Identify Data Integrity risks and impacts across CAPA, non-conformances, clinical quality events, protocol deviations, and change controls.
• Represent Data Integrity interests during supplier, internal, and third-party audits.
• Build alignment with Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, Warehouse, Facilities, and Commercial Operations leaders.

Requirements

• Strong background in GxP computer system validation or a technical field such as IT, software development, clinical data management, or data sciences, with hands-on GxP experience.
• BS/BA degree with 5+ years of related experience, or a master’s degree with 3+ years of related experience; life sciences, engineering, computer science, or a related technical degree is preferred.
• Experience with Data Integrity, ALCOA+, or data sciences in a human pharmaceutical or medical device company.
• Experience with risk and impact assessments and Computer System Validation, including knowledge of 21 CFR Part 11.
• Knowledge of GMP quality management systems, risk assessment frameworks, clinical laboratory regulations, protected health information, medical device submissions, and regulated clinical study standards.
• Hybrid work in Sunnyvale, California, United States is required.

Nice to have

• Excellent communication and documentation skills.
• Analytical approach with strong prioritization, planning, and independent-work skills.
• Quality-focused mindset.

Culture & Benefits

• Hybrid workplace.
• Flexible time off or vacation.
• 401(k) retirement plan with employer match.
• Medical, dental, and vision coverage.
• Well-being programs and additional compensation opportunities, including an annual bonus or other incentives.