Ardence Consulting

Senior Validation Consultant

Pennsylvania, US

Contract
17 days ago
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Summary

Sr. Validation Consultant (Sr. Manager Level to Associate Director Level)

This is a 12+ month assignment with an opportunity for extension

Targeted Start Date: ASAP


Assignment Overview:

Our client is a biotech company in immediate need of a Sr. Validation Consultant to support a facility build out.


Key responsibilities:

  • Provide quality oversight for commissioning, qualification, and validation of manufacturing and lab systems
  • Review and support investigations for deviations related to equipment, utilities, automation, and lab instruments
  • Review/approve change controls and risk assessments


Technical requirements:

  • Bachelor's degree in life sciences, engineering, or related field.
  • 10+ years in Quality Assurance and Validation
  • Strong technical writing and digital documentation skills (Veeva, CMMS)
  • Strong working knowledge of FDA, ICH, and EU regulations

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