Intertwined

CSV Specialist

Full Time
Allentown, PA, USA
Description

The Denzel Group has been chosen to work with a global industry leader based in Eastern, PA on their open Computer Systems Validation Specialist role. This Full-Time/Permanent opportunity offers excellent benefits and a fantastic work environment! In this role you will establish guidelines for computer system validation and implement validation plans and protocols based on analysis of functional and system specifications. You will ensure compliance with company policies through implementation of regulatory controls and industry best practices.

Requirements
  • Experience with Regulatory Controls: FDA 21 CFR Part 11, ALCOA, validation and risk-based understanding

  • Collaborating with business users, IT personnel, Business Analysts to define validation requirements and plans

  • Familiarity with IT Infrastructure and ability to collaborate with SME’s to write and revise SOPs

  • 5+ years’ experience in IT Validation field

  • Technical Writing (Plus)


To apply please send your application to tostrow@thedenzelgroup.com


#IND1


IT Validation, CSV, Computer Systems Validation, FDA 21, documentation, specialist


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