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Validation Engineer / CSV Engineer

Validation Engineer / CSV Engineer

Katalyst Healthcares & Life SciencesWalnut Creek, California, United States
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Job Description

Responsibilities :

  • Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
  • Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
  • Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
  • Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
  • Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional Plan.)
  • Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
  • Traceability Matrix.
  • Periodic Reviews.
  • System Retirement / Decommissioning.
  • Execution of Dry / Test protocol run.
  • Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
  • Perform System Retirement / Decommissioning of systems not in business.
  • Work closely with software development and IT teams to establish best practices for quality and compliance.
  • Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
  • Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.

Requirements :

  • A Minimum bachelor's degree in engineering, Science or related technical field.
  • Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
  • Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
  • Experience with non-product software validation, including tools for development, testing, and maintenance.
  • Good knowledge and experience of CSV activities but not limited to.
  • GxP and 21 CFR Part 11 applicability / criticality assessment.
  • Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
  • Execution of Dry / Test protocols.
  • Conduct Periodic Reviews of systems.
  • Perform System Retirement of systems that are not in business.
  • Understanding of Medical Device Quality and Compliance.
  • Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
  • Working experience in Product Lifecycle Management (PLM) tool.
  • Sound knowledge of computer system development lifecycles.
  • Knowledge of JIRA, JAMA software and test automation is a plus.

    • Additional Information

    All your information will be kept confidential according to EEO guidelines.

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    Validation Engineer • Walnut Creek, California, United States