Validation Lead SME

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