Computer System Validation – CSV Engineer

Raritan, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Role - Computer System Validation CSV Engineer

Location - Raritan NJ(Hybrid)

Job Qualification:

Experience in validating laboratory and labeling systems
5 years experience with System Development Lifecyle 10 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 (etc. Requirements Compliance Plans test protocols Test Summary reports and Compliance Reports
Experience in reviewing system test and user acceptance test scripts defect management 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
Technology Quality representative and provide quality guidance from a CSV perspective based on the J&J CSV Framework and SDLC process 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

Job Role - Computer System Validation CSV Engineer Location - Raritan NJ(Hybrid) Job Qualification: Experience in validating laboratory and labeling systems 5 years experience with System Development Lifecyle 10 years experience in Computer System Validation (Based on the role selected) Ex...