Lead Validation SME – Working Manager (6-month Contract)

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

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.