CSV Engineer

Raritan, NJ, US • Posted 60+ days ago • Updated 12 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Enterprise Resource Planning
  • SAP
  • SAP ERP
  • MES
  • Manufacturing
  • JIRA
  • SAP Solution Manager
  • Test Scripts
  • Communication
  • Supervision
  • Management
  • Computerized System Validation
  • GxP
  • Writing
  • Documentation
  • Regulatory Compliance
  • System Testing
  • Traceability Matrix
  • Specification Gathering
  • Test Methods
  • Test Plans
  • Acceptance Testing
  • Scripting

Summary

Summary
  • Mandatory - Validation experience with ERP applications / SAP / MES
  • Experience in validating ERP/SAP/ MES Manufacturing applications
Roles & responsibility
  • 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.
Education & Experience
  • 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 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/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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: a9726dc62cd6bad19db1a9154b1ed9ad
  • Posted 30+ days ago
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