Automation, Biotech and Pharmaceutical, Capital Expenditure (CAPEX), Change Control, Commissioning, Design Verification, Documentation, Drug Manufacturing, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), ICH Regulations, Maintain Compliance, Regulatory Compliance, Risk, Risk Analysis, Traceability, Verification Plans, Warehousing
Hello,
I hope you're doing well.
My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Design Verification Lead based in Huntsville, AL / Richmond, VA with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com
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.
Key Responsibilities:
- 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.
Requirements:
- Strong experience in Design Verification (DV) within pharmaceutical CAPEX projects and facility buildouts.
- Extensive expertise in P&ID review 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.
Thanks & Regards,
Vyshnavi
Recruiter
Intellectt Inc
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225