Design Verification Lead
Job in
Huntsville, Madison County, Alabama, 35824, USA
Listed on 2026-06-30
Listing for:
Intellectt INC
Full Time
position Listed on 2026-06-30
Job specializations:
-
Engineering
Quality Engineering, Validation Engineer, Pharma Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
Role
Design Verification Lead
Location:
Huntsville, AL / Richmond, VA
Duration:
Long-Term
Summary:
We are seeking an experienced Design Verification Lead to support the delivery of a new pharmaceutical drug substance manufacturing facility.
- Lead design verification activities for facilities, equipment, utilities, automation, and process systems.
- Review and approve engineering, vendor, and design documentation, including P&IDs.
- Develop and execute Design Verification Plans, protocols, reports, and traceability matrices.
- Ensure compliance with GMP, FDA, EMA, ISPE, and ICH Q8 Q11 requirements.
- Support risk assessments, change control, design qualification, commissioning, and FAT/SAT activities.
- Review material flow, personnel flow, and warehouse layouts for operational and regulatory compliance.
- Coordinate with vendors and project stakeholders to ensure design alignment and project success.
- Strong experience in Design Verification (DV) within pharmaceutical CAPEX projects and facility buildouts.
- Extensive expertise in P&w and design verification.
- Knowledge of GMP regulations, FDA/EMA expectations, ISPE guidelines, and ICH Q8 Q11.
- Experience with URS, FDS, DDS, change control, FAT/SAT, commissioning, and risk-based qualification.
- Excellent stakeholder management and technical review skills.
Vyshnavi
Recruiter, Intellectt Inc
Email:
Direct:
Desk number: - Ext: 225
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