CQV Engineer

Job Title: Validation Engineer II (Onsite)

Location: Bothell, WA

Job Overview

We are looking for a skilled Validation Engineer II with 5–8 years of experience in CQV and validation activities within a GMP-regulated biotech or pharmaceutical environment. This is a hands-on role focused on supporting equipment qualification, process validation, and overall CQV execution.

Key Responsibilities

• Execute equipment qualification activities including IQ, OQ, and PQ for GMP systems
• Support commissioning, qualification, and validation (CQV) efforts across equipment and systems
• Author, review, and execute validation protocols and reports
• Assist with process validation activities, including PPQ
• Collaborate with cross-functional teams including Engineering, Manufacturing, and Quality
• Support investigations, deviations, CAPAs, and change control activities related to validation
• Ensure compliance with GMP regulations and company quality standards

Required Qualifications

• 5–8 years of experience in CQV / Validation within pharmaceutical or biotech industries
• Strong hands-on experience with equipment qualification (IQ/OQ/PQ)
• Solid understanding of GMP regulations and compliance requirements
• Experience authoring and executing validation documentation
• Ability to work onsite and effectively collaborate with cross-functional teams

Preferred Qualifications

• Experience with cleaning validation
• Exposure to process validation (PPQ)
• Experience with utilities or facility qualification
• Background in biologics or drug substance manufacturing