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Computer System Validation Engineer
Computer System Validation EngineerKatalyst HealthCares & Life Sciences • Vacaville, CA
Computer System Validation Engineer

Computer System Validation Engineer

Katalyst HealthCares & Life Sciences • Vacaville, CA
Hace más de 30 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

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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