Medical Device Packaging Validation Engineer

Pittsburgh, PA

Job ID: 126756 Industry: Med
   
Packaging  Validation Engineer

Environment:

Our client is a medical device organization that develops a number of radiology and CT devices. They are currently working on validating a new production line for their devices, and have a robust team of engineers executing a project with multiple facets pertaining to the validation of equipment/devices. Our client wishes to move full time employees back into sustaining roles and supplement the team with an experienced  consultant well-versed in packaging validation and ready to hit the ground running.

Scope of Work:

This  consultant will be from a Medical Device background, and must have experience validating Packaging Equipment.  The consultant will be writing and executing packaging validation protocols (IQ/OQ/PQ), performing process and Test Method validations, process design validations, etc.The client uses a  primary packaging process, has a thermoformed packaging process in place and some multipack processes as well.

  General responsibilities will include:
  • Writing & Executing Packaging Equipment/Process Qualifications, IQ/OQ/PQ Testing Protocols.
  • Write Validation Summary Reports
  • Validation of Documentation
  • Execute Validations (Packaging, Process, TMV, etc.)
    • Creating sample sizes, DOEs,  etc.

 

Required:
  • Medical Device: 5-8+ years
  • Writing & Executing Packaging Equipment Validation Protocols/Documentation: 5-8+ years
  • Extensive background validation Packaging Equipment
  • Very strong communicator

Plus:
  • Able to work alongside engineers of all levels
  • Radiology

Job Type: Contract   

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