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Senior Validation Engineer

Il y a 2 mois

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Position: Senior Validation Engineer - Analytical Systems

Evotec WD is on the lookout for a dedicated and skilled Analytical Systems Validation Engineer who is eager to make a meaningful impact in enhancing global access to biotherapeutics.

The main objective of this position is to assist in the Commissioning, Qualification, and Validation (CQV) of facilities, particularly focusing on Analytical Systems.

This role encompasses all stages of the validation lifecycle, including:

  • System implementation
  • System qualification
  • System support and maintenance
  • System retirement

Key responsibilities include:

  • Supporting the creation and/or evaluation of essential documents such as User Requirements Specifications, System Impact Assessments, Criticality Assessments, Data Integrity Assessments, Design Qualification, Requirements Traceability Matrices, and protocols for Commissioning, IQ, OQ, and PQ related to Analytical Systems.
  • Contributing to the resolution of validation deviations through troubleshooting and root cause analysis.
  • Assisting in the development of qualification and validation programs at Evotec WD.

The ideal candidate will possess a Master’s degree in engineering or a related field, along with over 8 years of pertinent experience in a GMP environment.

Experience in authoring and reviewing validation documentation is essential.

Strong verbal and written communication skills in both English and French are required.

Familiarity with Paperless Validation Software and a solid understanding of Computer Systems Validation will be advantageous.

Join us in our commitment to excellence and innovation in the biotherapeutics sector.