Computer System Validation Engineer /Validation Engineer

Position: Computer System Validation Engineer /Validation Engineer

Location: Santa Clara, CA (Onsite)

Duration: 6 months

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

                          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.

Essential Skills:

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.

Desirable Skills:

“•      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.”

Education: At least a bachelor’s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or closely related field is required.

Thanks, and regards

Ganesh Gorak
ganesh.g@itechus.net

Itech Us Inc