Pharmaceutical Validation Engineer

Denver, CO

Industry: Pharmaceutical Job Number: 134105

 

Pharmaceutical Validation Engineer

Project Description:

Our client is a pharmaceutical company looking for a validation engineer to qualify new commercial equipment.

Day to Day Responsibilities:

The client is looking for validation engineer to provide automation support for the following:
  • Review and feedback for revision of supporting lifecycle documentation (URSs, FRSs, DDSs, etc.) Process Skid, CIP Skid, associated system Vessels and automated systems.
  • Generation/Revision URSs for WFI, USP, Facilities, associated utilities, etc.
  • Generation of Validation Plan
  • Review and feedback for revision of FATs, SATs, Commissioning
  • Provide support for execution of Commissioning activities and associated documentation review.
  • Generate and execute Installation and Operational Qualification protocols and reports
  • Champion efforts to perform automated systems alarm assessment using DDS documentation
  • Provide process development support to determine system boundaries from an automation perspective

This individual must have a solid background and vast experience in PLC and qualification of automated manufacturing equipment i.e. authoring IQ, OQ, PQ protocols and reports in addition to execution of qualification activities.

Required
  • Computer Systems Validation
  • Automation
  • Equipment Validation / Qualification 
  • Engineering 
  • Pharmaceutical cGMP

Job Type: Contract 

 

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