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Shipping Validation Engineer

  1. United States
Seattle
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
34852
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Shipping Validation Engineer - Pharma - Seattle - 6-Month Contract 

Our client, a global biotechnology organisation, is recruiting for a Shipping Validation Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a Shipping Validation Engineer to help expand our client's biotech operations throughout Europe. As the Shipping Validation Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.


Responsibilities and requirements: 

  • Develop complex equipment validation strategies and execute intricate validation qualifications.
  • Perform Validation Maintenance/Quality Systems review and requalification activities to ensure GMP equipment is continuously maintained in a validated state.
  • Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements.
  • Program, organise, and maintain Validation equipment and supplies including Data Acquisition systems for temperature mapping.
  • Demonstrate a thorough understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Qualification (IQ), Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment. Develop validation protocols from Validation plans and engineering documents.
  • Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations.
  • Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and TrackWise system (Change Control, Deviations, CAPA, etc.).


If this role is of interest to you, please apply now! 

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