System Validation Engineer (6-8 yrs)

Role : System validation engineer

Location : Remote

Exp : 6+ years

Job Overview :

The Systems Validation Engineer will be a technical expert responsible for leading Systems Engineering activities related to Data Migration across GxP and Non-GxP systems. Develop, review, implement and maintain complete validation cycle documentation including validation plan, user requirements, functional requirements, systems design, gap analysis, test strategies, test protocols, test cases, test reports, deviation reports, validation report, and traceability matrices for system verification.

Responsibilities :

- Lead the development and approval of the Validation Strategy, Validation Master plan, Validation protocols, and Validation Summary Reports.

- Possess expertise in creating and managing User Requirement Specifications, Functional Specifications, User Stories, Acceptance Criteria, and System Design documents.

- Design, author, and execute Validation Protocols Documents including Installation qualification, Operational qualification, Performance Qualification, to verify data integrity throughout the data migration and system validation process.

- Develop, review, and execute test strategies, test protocols, test cases, test reports, and traceability matrices for system verification.

- Performs Risk Assessment, ensuring all user requirements and test cases are designed with reference to the identified risk levels.

- Ensures adherence to Change control and configuration management procedures throughout the Project life cycle, including the recovery procedures, validation of backups, deviation/exception handling processes.

- Coordinates with the project team members to plan and execute validation goals and work closely with functional leads to optimizing the test scope, test scenarios and test execution strategy.

- Ensure all validation documents comply with corporate quality standards, procedures, and regulatory requirements.

Requirements :

- Bachelors degree is required

- Experience in Pharma Life sciences validation of enterprise level systems and data migration initiatives

- 5 years Experience in Validating GxP and Non GxP related systems and applications

- Experience working in both an Agile and Waterfall based Software Development environment

- Excellent written and verbal communication skills including cross functional communication experience.