Validation Engineer

Job Title: Validation Engineer II (Onsite)

Location: Bothell, WA

Duration: 12 months (potential for extension)

Overview:

We are seeking a CQV / Validation Engineer with 5–8 years of experience to support validation and qualification activities within a GMP-regulated biotech environment. This is a hands-on role supporting equipment, process, and CQV execution.

Key Responsibilities:

• Execute equipment qualification activities (IQ/OQ/PQ) for GMP systems
• Support commissioning and qualification (CQV) efforts across equipment and systems
• Author and execute validation protocols and reports
• Support process validation (PPQ) activities
• Collaborate with engineering, manufacturing, and quality teams
• Assist with deviations, CAPAs, and change controls related to validation
• Ensure all activities are performed in compliance with GMP requirements

Required Experience:

• 5–8 years of experience in CQV / Validation within pharma or biotech
• Strong hands-on experience with equipment qualification (IQ/OQ/PQ)
• Experience working in GMP-regulated environments
• Experience authoring and executing validation documentation
• Ability to work onsite and cross-functionally with multiple teams

Preferred (Nice to Have):

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

Additional Notes:

• Interview process includes resume review and team interviews
• Potential for long-term engagement