Design Verification Lead

Role: Design Verification Lead Consultant
Locations: Huntsville, AL & Richmond, VA

Role Summary
We are seeking an experienced Design Verification Lead Consultant to ensure that all new and modified equipment, systems, utilities, and processes within a drug substance manufacturing facility meet intended design requirements and regulatory expectations.
This role supports a facility build-out (CAPEX) project for clinical and commercial manufacturing operations and provides hands-on leadership across engineering, manufacturing, quality, and validation functions.
The position serves as a technical authority for design verification activities, ensuring compliant, efficient, and fit-for-purpose facility design and execution.

Key Responsibilities
Lead end-to-end Design Verification (DV) activities for facilities, equipment, automation, and process systems
Support CAPEX pharmaceutical facility build-out projects, including site expansions and new facility design
Ensure compliance with GMP regulations and applicable guidance (FDA, EMA, ICH Q8–Q11, ISPE)
Conduct detailed P&ID reviews (line-by-line) and support verification from concept through execution
Support early-stage, conceptual, pre-conceptual, and detailed design phases
Develop and implement change control strategies for facility build-out and design evolution
Evaluate material flow, personnel flow, and warehouse logistics flow
Interface with vendors to ensure scope alignment, technical compliance, and quality expectations
Coordinate design timelines with FAT and SAT testing activities
Author, review, and approve:
Design Verification Plans
Protocols and Reports
Traceability Matrices
Risk Assessments
Act as Design Verification authority and technical lead for assigned scopes
Develop User Requirements Specifications (URS) in cross-functional environments
Ensure requirement traceability, testability, and technical feasibility across systems
Review vendor deliverables including:
Functional Design Specifications (FDS)
Detailed Design Specifications (DDS)
Engineering design packages
Support risk-based qualification, verification, and commissioning activities

Required Qualifications
Strong experience in Design Verification for pharmaceutical facilities, equipment, automation, and process systems
Hands-on experience in CAPEX pharmaceutical facility build-outs (site expansion experience preferred)
Strong knowledge of GMP regulations and industry guidance (FDA, EMA, ICH Q8–Q11, ISPE)
Extensive experience in P&ID development and detailed line-by-line review
Proven experience across early-stage, conceptual, and detailed design phases
Experience executing change control strategies in greenfield or expansion projects
Understanding of material, personnel, and warehouse flow design
Experience working with vendors and managing technical scope and deliverables
Experience aligning engineering deliverables with FAT/SAT execution
Strong capability in developing and executing design verification documentation packages
Show more Show less