Medical Device Equipment/Clean Room Validation

Memphis, TN

Job ID: 127678 Industry: Med

 

Medical Device Equipment/Clean Room Validation

Environment:

Our client is a large medical device manufacturer. They develop and manufacture a number of  medical devices.  They recently acquired a small Biologics company that produces artificial human tissue. A gap assessment has been performed and now they are in need of a qualified validation engineer to support execution and remediation of equipment validation in a clean room.

Scope of Work:

Our client seeks a seasoned validation engineer to support the following. 
  1. Working in a Medical Device/Human Tissue clean-room processing facility
  2. Writing validation (IQ/OQ/PQ) protocols
  3. Executing validation protocols
  4. Writing final validation reports
  5. Cleaning validations
  6. Sterilization validations
  7. Equipment validations
  8. Environmental monitoring equipment validations/facility validations

The actual Master Validation plan has already been created, and this person will be executing actions items that were identified throughout thorough gap assessments. The facility produces human tissue which has its own FDA justifications, yet most of the validation procedures are standard like most medical devices. Some equipment just requires install (IQ) while others require more validation. The client seeks someone hands on, who can communicate effectively with the team and report findings/updates back to management.

Required Experience:
  • Medical Device: 7+ plus years
  • Equipment/Clean Room Validation
  • Validation Gap Assessment experience
  • ISO 13485

Plus:
  • Human Tissue or similar

Job Type: Contract

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