What are the responsibilities and job description for the Validation Engineer position at Intellectt Inc?
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