CSV Lead

Princeton, NJ, US • Posted 1 day ago • Updated 5 hours ago
Contract Corp To Corp
Contract W2
12 Months
No Travel Required
Able to Sponsor
On-site
$60 - $65/hr
Company Branding Image
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Acceptance Testing
  • Biotechnology
  • Documentation
  • GxP
  • Medical Devices
  • Pharmaceutics
  • Scripting

Summary

This role will be supporting validation leads to help ensure the required deliverables and testing are complete according to the Client CSV SOP.
Effective communication is key across a multi-functional team consisting of Business, IT, and Quality personnel.
Overall a solid CSV background and a strong work ethic in an aggressive project setting will be key to success in this role.

 
Required Skills:

  • Experience in the pharmaceutical, biotechnology, or medical device industry
  • 10+ years of experience in Computer System Validation (CSV)
  • Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation
  • Knowledge of FDA guidance and industry standards (e.g., GAMP)
  • 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
  • Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports)
  • Experience in reviewing system test and user acceptance test (UAT) scripts, Traceability Matrix, and Design Specifications
  • Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT 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: 10115656
  • Position Id: CSV-6/22
  • Posted 1 day ago

Company Info

About Amzur Technologies, Inc.

Amzur Technologies, Inc. (Amzur) is an award-winning, ISO 9001:2008 certified company based in Tampa, FL, serving customers across the globe. Our main focus is on IT services that help SMB companies accelerate their business growth.

We operate as a trusted IT partner at every stage in our customer’s digital transformation journey and specialize in simplifying IT transformation. And we do this through a proven framework that brings together hyperautomation, application modernization & managed services to enable its customers with the agility and speed to stay competitive in all markets. With employees & teams spread across three continents, we are able to deliver the right talent and highly targeted services for ensuring the success of all our customers..

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Contact the job poster
Prabhakar Nirujogi

Prabhakar Nirujogi

Recruiter @ Amzur Technologies, Inc.
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