Medical Device Computer Systems Validation Engineer

Newark, NJ

Industry: Med Job Number: 128696

 

CSV Engineer

Environment:  Our client is a large medical device manufacturer that develops a number of Class III medical devices. They are currently in need of a CSV Engineer to support Software Validation activities within an ongoing remediation. The software validations will be for both manufacturing equipment and software related product components. 

Responsibilities: The client is currently in the midst of an on-going remediation project.   The client is in need of a CSV Engineer for non-product Software Validation. This individual will be from a Medical Device background and must have experience remediation Software Validations and reviewing protocols for software validation to make recommendations etc.

The consultant will need to understand FDA Regulatory requirements associated with Software V&V and GMP. This consultant should have experience in a remediation environment.

Required:
  • Medical Device
  • Software Validation: 7+ years
  • GMP
  • Remediation Experience

Plus:
  • Cardiac Devices

Job Type: Contract

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