CSV Engineer
Role – CSV Engineer
Location – Raritan, NJ(Hybrid 3 days a week)
Job Details:
• 7-10 years’ experience in Computer System Validation ERP/WMS, R&D systems
• Responsible to lead validation of ERP/WMS, R&D and Commercial systems
• Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
• Application of FDA guidance’s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
• Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report
• Must be familiar with procedures, work instructions, forms and templates
• Solid understanding of SDLC, Jira, QTest, automated test tool like TOSCA, code repository like bitbucket and change control/ management systems like IRIS and Solman
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