Computer engineer [h1.location_city]
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Computer engineer • fairfield ca
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Computer System Validation engineer
Katalyst HealthCares & Life SciencesVacaville, CA[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Experience with CSV in a regulated pharmaceutical or biotech environment. Strong knowledge of GxP, FDA CFR Part , and EU Annex . Proficiency in authoring and executing validation documentation.
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 CFR Part , EU Annex , 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 :