Validation Lead SME

Gardner Resources Consulting, LLC; Bothell (WA); On-site; USD 100,000 - 150,000; Full time

Job summary

A consulting firm seeks an experienced Validation Subject Matter Expert in Bothell, WA for a 6-month contract. The role combines hands-on technical validation work and team leadership, requiring over 15 years of experience in validation across pharmaceuticals, biotech, or medical devices. Key responsibilities include authoring validation documentation, managing validation engineers, and ensuring compliance with FDA and EU GMP regulations. On-site presence is mandatory for the role with a project start date of April 13.

Qualifications

• Minimum 15+ years of experience in pharmaceutical or biotech validation.
• Demonstrated expertise across multiple validation domains.
• Proven experience in a validation management or leadership role.

Responsibilities

• Act as primary Validation SME providing expert guidance.
• Author and approve validation documentation.
• Manage and mentor a team of validation engineers.

Skills

Pharmaceutical validation expertise

Leadership in validation management

FDA regulatory knowledge

Technical writing skills

Cross-functional team collaboration

Education

Advanced degree in Engineering or Life Sciences

Job description

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.)
• 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 elevate 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
• 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