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Urgent! Validation Engineer/CSV Engineer Job Opening In Walnut Creek California – Now Hiring Katalyst Healthcares & Life Sciences

Validation Engineer/CSV Engineer



Job description

Job Description:


  • 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.



Responsibilities:


  • 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) too.


  • sound knowledge of computer system development lifecycles.


  • Knowledge of JIRA, JAMA software and test automation is a plus.

    "

  • Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.





Required Skill Profession

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