Computer System Validation EngineerKatalyst HealthCares & Life Sciences • Vacaville, CA
Computer System Validation Engineer
Katalyst HealthCares & Life Sciences • Vacaville, CA
30+ days ago
Job type
- Full-time
Job description
Job Summary:
Roles & Responsibilities:
Education & Experience:
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:
- 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 CFR Part , and EU Annex .
- Proficiency in authoring and executing validation documentation.
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Computer System Validation Engineer • Vacaville, CA
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