Validation Engineer/CSV EngineerKatalyst HealthCares & Life Sciences • Walnut Creek, CA
Validation Engineer / CSV Engineer
Katalyst HealthCares & Life Sciences • Walnut Creek, CA
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]A Minimum bachelor's degree in engineering, Science or related technical field. Minimum of - years of experience in software quality assurance or software validation, preferably within the medical device industry. Strong understanding of quality standards and regulatory requirements (, FDA CFR Part , ISO , IEC ). 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 CFR Part 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 CFR Part 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.
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 , IEC ) 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 CFR Part .
- 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 :
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Validation Engineer • Walnut Creek, CA
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