CSV Engineer
eTeam Inc
Job Role - CSV Engineer
Location - Raritan, NJ (Hybrid)
Job Summary and Required Skills:
- Experience in validating Windchill, Product Lifecycle Management (PLM)
- 3 years' experience with System Development Lifecyle
- 7 years' experience in Computer System Validation (Based on the role selected)
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation
- Experience in writing and executing documentation for all aspects of the validation deliverables (e.g. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports)
- Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs
- Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures
- Preferred tools knowledge and experience: JIRA, qTest, ServiceNow, XRAY and Change Record review
- Experience in Test scripts, executions and defect reviews
- Strong verbal and written communication skills
- Ability to work as a team player, lead a team or accomplish tasks without supervision
- Ability to work with remote teams and support several changes/projects simultaneously
- Ability to provide Validation guidance, timely reviews, and escalations to TQ management
Vacancy posted 14 hours ago
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