CQV Engineer

CQV Engineer at United Pharma Technologies Inc CQV Engineer at United Pharma Technologies Inc in MILL CREEK, Washington Posted in 2 days ago.

Type:

full-time

Job Description:

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