Validation Engineer/CSV Engineer

- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. - We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.  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. All your information will be kept confidential according to EEO guidelines.