Validation Engineer

Validation Engineer at Intellectt, Inc Validation Engineer at Intellectt, Inc in Kenmore, Washington Posted in 2 days ago.

Type:

full-time

Job Description:

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