CSV Specialist

San Diego, CA

Job ID: 129082 Industry: Med

CSV Specialist

Environment

Our client is a large global organization that makes a variety of medical devices and diagnostic products. They are in need of a hands-on CSV Specialist to come in and provide Software Validation support.

 

Responsibilities:

The CSV  Specialist will be coming in to write, execute and summarize  software validation documentation such as Validation Plans, User Requirements, Functional Requirements, Design Specifications, Risk Management Plans, IQ / OQ / PQ protocols, Traceability Matrices, Final Reports and Test Deviation Handling. Some of of the client' s systems that this individual will be validating will require both writing and execution, while other systems  already have protocols written and will only require execution. It wold be a huge plus if this individual has experience validating  Agile PLM (an Oracle Product Lifecycle Management software). It would also be preferred if this individual has experience validating BarTender (a Labeling software). 

 

Required Experience:
  • Medical Device/Pharmaceutical: 5-8+ years
  • CSV / Software Validation: 5-8+ years
  • Writing & Executing Validation Documents: 5-8+ years
  • Agile PLM

Preferred Experience:
  • BarTender (Labeling Software)

Job Type: Contract

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