Job Title: Senior Validation Engineer / Validation Manager
Location: Near Seattle, WA (100% Onsite)
Duration: 6 Months Contract (High likelihood of extension or full-time conversion)
Job Summary:
We are seeking an experienced Senior Validation Engineer / Manager to serve as the Site Validation Subject Matter Expert (SME). This is a hands-on leadership role requiring both strategic oversight and execution across multiple validation disciplines. The ideal candidate will be capable of independently driving validation activities, ensuring regulatory compliance, and leading a small team in a fast-paced environment.
Key Responsibilities:
- Act as the primary Validation SME across all site validation activities
- Author, review, and approve validation documentation including VMPs, protocols, and reports
- Ensure compliance with FDA, EU GMP, and ICH regulatory standards
- Lead, mentor, and manage a team of validation engineers (~3 members)
- Oversee and coordinate work of external validation contractors
- Own and manage validation schedules, priorities, and deliverables
- Identify validation risks and compliance gaps; proactively escalate issues
- Collaborate cross-functionally with QA, Manufacturing, Engineering, and Regulatory teams
- Support internal/external audits and regulatory inspections
Required Qualifications:
- 15+ years of validation experience in Pharma, Biotech, or Medical Device industries
- Strong expertise in:
- Cleaning Validation
- Utilities Validation (PW, WFI, HVAC, Compressed Air)
- Equipment Qualification (IQ/OQ/PQ)
- Computer System Validation (CSV – GAMP 5, 21 CFR Part 11)
- Shipping / Distribution Validation
- Proven leadership and team management experience
- Deep understanding of FDA 21 CFR, EU GMP, and ICH guidelines
- Strong technical writing and documentation skills
- Experience supporting regulatory inspections and audit readiness
- Bachelor’s degree required (Advanced degree preferred)