Computer System Validation engineer
Katalyst CRO • Vacaville, California, United States
Salary: 21 CFR Pa
Summary
As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11,
Full Description
Summary
As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure 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 regulations.
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 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.
