Director of Validation
Sacramento, CA
Onsite
Target Salary: $160,000

Kelly Engineering is seeking a Director of Validation for a sterile pharmaceutical manufacturing facility in Sacramento, CA.

This leadership role is responsible for overseeing and advancing all validation activities across a commercial sterile manufacturing site. The Director of Validation ensures that facilities, utilities, equipment, processes, cleaning systems, and computerized systems remain in a validated state in full compliance with FDA and global regulatory requirements.

Key Responsibilities

• Lead and execute the site Validation Master Plan
  

• Oversee validation for aseptic processing and fill/finish operations
  

• Direct cleanroom and controlled environment validation
  

• Manage utilities validation including WFI, clean steam, HVAC, and compressed gases
  

• Oversee equipment qualification including autoclaves, washers, filling lines, isolators, and RABs
  

• Lead process validation including PPQ and continued process verification
  

• Direct cleaning validation and computerized systems validation
  

• Serve as validation subject matter expert during regulatory inspections
  

• Partner cross-functionally with Quality, Engineering, Manufacturing, Automation, IT, and Regulatory Affairs
  

• Lead and develop a team of validation engineers and managers
  

• Drive risk-based validation and continuous improvement initiatives

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
  

• 10+ years of validation experience within GMP pharmaceutical manufacturing
  

• Minimum 5 years of leadership experience in sterile or aseptic environments
  

• Strong knowledge of FDA, EMA, ICH, and Annex 1 requirements
  

• Experience supporting FDA inspections and commercial manufacturing operations
  

• Deep expertise in lifecycle validation and risk-based approaches

Additional Requirements

• Must live within or be willing to relocate to the Sacramento Metropolitan region
  

• Onsite presence required to support sterile manufacturing operations
  

• This is an opportunity to lead validation strategy at a growing commercial sterile facility while ensuring regulatory compliance, patient safety, and operational excellence.

If you have a strong background in sterile validation leadership and are ready to drive impact at a site level, we encourage you to apply.

10129723