Computer System Validation EngineerKatalyst HealthCares & Life Sciences • Vacaville, CA
Computer System Validation Engineer
Katalyst HealthCares & Life Sciences • Vacaville, CA
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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 . Experience with Computer System Validation (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.
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 CFR Part , EU Annex , and other applicable regulatory requirements.
Roles & Responsibilities :
Education & Experience :
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