Quality Engineer III
$107.19k - $138.71kGilead
Gilead Sciences seeks a Quality Engineer III to serve as subject matter expert in computer system validation, data integrity, and quality risk management. The role provides quality oversight and regulatory compliance support for systems, facilities, and processes in a biotechnology manufacturing environment.
Responsibilities
- Provide quality oversight for Computer System Validation and Commissioning, Qualification, Validation activities
- Maintain site Data Integrity and Quality Risk Management programs to ensure regulatory compliance
- Review and approve validation, qualification, risk assessment documentation, protocols, and technical assessments
- Perform quality impact assessments for change controls, deviations, investigations, and CAPAs
- Support internal audits, regulatory inspections, compliance readiness, and gap assessments
Requirements
- Bachelor's degree in Engineering, Life Sciences, Computer Science, Quality, or related field with 5+ years quality/validation experience; or Master's degree with 3+ years relevant experience
- Computer Software Assurance (CSA) certification or equivalent
- Experience supporting Computer System Validation (CSV), Commissioning, Qualification and Validation (CQV), Quality Systems, or Data Integrity programs
- Working knowledge of GxP, FDA, EU GMP, 21 CFR Part 11, Annex 11, and Data Integrity principles
- Ability to review and interpret technical documentation, validation deliverables, and quality records
- Strong verbal and written communication skills with cross-functional collaboration ability
Compensation: $107,185-$138,710 base
Vacancy posted 3 days ago
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