IVD Test Method Validation Engineer (Remote Availability)

Seattle, WA

Job ID: 131106 Industry: Med

IVD Test Method Validation Engineer (Remote Availability)

 Background:

Our client is a large IVD/Diagnostics manufacturer. They are currently in need of someone to come in and support the design and protocol writing for Test Method Validation for IVD/Diagnostics. They have some procedures written, but need assistance with the execution portion of over 25+ Test Method Validations.

Responsibilities:

This person will be responsible for supporting the the execution of 25+ TMVs for an IVD/Diagnostics company. They have about 70% of their TMV plan in place and some procedures written, but where they need support is in the design of TMVs and writing of protocols. This person will work directly with scientists and biostaticians, who can perform Gage R/R. Their statisticians have not done TMV so will rely heavily on this consultant to own most of the execution and provide some knowledge on the topic. This person should come from a scientific/analytical background, seeing as the role does not pertain to a very mechanical device. Work experience with In-vitro Diagnostics, IVD Assays, Analytical & Non-analytical Assays and Bioanalytical TMV would be extremely beneficial.

Must be comfortable being in a hands-on execution role, this is NOT a “ review and approve” type role.

Required:
  • IVD/Diagnostics experience (Med Device/Pharma is suitable, IVD Preferred)
  • Test Method Validation
  • Analytical/Scientific background
  • Ability to work efficiently with other engineers in a team setting

Plus:
  • Test Method Validation for IVD
  • Assays
  • Bioanalytical TMV

Job Type: Contract  

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