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Validation Subject Matter Expert (SME)
We are seeking a highly experienced Validation Subject Matter Expert (SME) for a 6-month contract engagement to fill a critical leadership gap created by the retirement of our Validation Manager. This is a working manager role, meaning the selected contractor will be expected to contribute both hands-on technical validation work and team leadership responsibilities.
Responsibilities: 
- Technical Validation Leadership
  • Serve as the site's primary Validation SME, providing expert guidance across all validation disciplines
  • Author, review, and approve validation documentation including Validation Master Plans (VMPs), protocols, and summary reports
  • Ensure all validation activities are compliant with applicable regulatory requirements (FDA 21 CFR Parts 11, 210/211, EU GMP Annex 11, ICH Q7/Q10, etc.)
- Team Management & Mentorship
  • Manage and mentor a team of 3 existing validation engineers, providing day-to-day direction, technical guidance, and performance oversight
  • Oversee and coordinate the work of additional validation contractors as needed
  • Foster a culture of quality, compliance, and continuous improvement within the validation team
  • Conduct knowledge transfer activities to build internal team capability and ensure continuity beyond the contract period
- Project & Program Management
  • Develop and maintain a validation project schedule aligned with site priorities and regulatory timelines
  • Identify and escalate risks or compliance gaps proactively
  • Interface with cross-functional teams including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs
  • Support regulatory inspections and internal audits as the validation SME
 
Must Have:   
  • Minimum 15+ years of experience in pharmaceutical, biotech, or medical device validation
  • Demonstrated expertise across multiple validation domains
  • Proven experience in a validation management or leadership role
  • Strong knowledge of FDA, EU GMP, and ICH regulatory frameworks
  • Excellent technical writing skills for authoring and reviewing GMP documentation
  • Ability to work on-site in Bothell for the duration of the contract

Nice to Have: 
  • Experience in a working manager capacity within a contract or consulting environment
  • Prior experience mentoring junior validation engineers
  • Familiarity with electronic Quality Management Systems (eQMS) and document control platforms
  • Experience supporting FDA inspections or PAI readiness
  • Demonstrate hands-on expertise in the following areas:
    • Cleaning Validation – Development and execution of cleaning validation protocols, establishment of acceptance criteria, and residue limit calculations
    • Utilities Validation – Qualification of critical utilities including purified water (PW), water for injection (WFI), clean steam, compressed air, and HVAC systems
    • Equipment Qualification – IQ/OQ/PQ execution and documentation for manufacturing and laboratory equipment
    • Computer Systems Validation (CSV) – Validation of computerized systems in accordance with GAMP 5 guidelines and 21 CFR Part 11 requirements
    • Shipping/Distribution Validation – Temperature mapping, thermal qualification studies, and lane qualification for controlled distribution
  • Advanced degree in Engineering, Life Sciences, or a related field

Contract Terms
  • Duration: 6 months (with potential for extension or full-time conversion)
  • Start Date: 4/13
  • Location: Bothell, WA – On-site presence required
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