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CSV Engineer
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2025-12-27
Listing for:
Shrive Technologies LLC
Full Time
position Listed on 2025-12-27
Job specializations:
-
IT/Tech
IT Consultant -
Engineering
Job Description & How to Apply Below
Mandatory – Validation experience with ERP applications / SAP / MES
Job Description- Experience in validating ERP/SAP/MES Manufacturing applications
- 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, SAP Solution Manager, XRAY and Change Record review
- Should be experienced 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
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