CQV Engineer

Job Title: Validation Engineer II (Onsite) Location: Bothell, WAJob OverviewWe 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 ResponsibilitiesExecute 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 Qualifications5–8 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 QualificationsExperience with cleaning validation Exposure to process validation (PPQ) Experience with utilities or facility qualification Background in biologics or drug substance manufacturing