Title: CSV Engineer
Location: Raritan, NJ (Hybrid 3 days a week)
Terms: Contract
Job Details:
Job Duties:
- 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 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
Regards,
Srijan Roy
Talent Acquisition Specialist
Cynet Systems