Senior Quality Validation Engineer

2 days ago


Hillsboro, United States Genentech Full time

Job Summary:

The Senior/Principal Quality Validation Engineer will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations, and industry standards to review and approve qualification and validation documents. This role will perform quality oversight of equipment, facility, and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods.

Key Responsibilities:

  • Review and approve qualification and validation documents
  • Perform quality oversight of equipment, facility, and utility systems
  • Develop new approaches to complex problems
  • Lead sub-streams or participate in global/large cross-functional project teams
  • Exercise judgment based on analysis of multiple sources of information

Requirements:

  • Bachelor's degree with 8 years industry experience or Master's with 5 plus years for a Senior or 12 years industry experience or Master's with 8 years for a Principal
  • Industry experience preferably in technical validation or quality validation
  • Recognized internally as an expert in own job discipline

What We Offer:

  • Competitive salary range of $88,000 - $163,000
  • Discretionary annual bonus
  • Relocation benefits
  • Equal opportunity employer


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