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Katalyst CRO • Vacaville, California, United States
Salary: 21 CFR Pa
Job Summary
As a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21
Job Summary
As a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulatory requirements.
Roles & Responsibilities
Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports. Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity. Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations. Provide training to stakeholders on validation requirements and best practices. Maintain validation lifecycle documentation and change control records .
Education & Experience
Experience with Computer System Validation (CSV) in a regulated pharmaceutical or biotech environment. Strong knowledge of GxP, FDA 21 CFR Part 11, and EU Annex 11. Proficiency in authoring and executing validation documentation.