Design Verification Lead

Overview

The Design Verification Lead is responsible for ensuring that all new and modified equipment, systems, utilities, and processes within a new drug substance manufacturing facility meet intended design requirements and regulatory expectations. This role provides technical leadership across engineering, manufacturing, quality, and validation functions and plays a critical role in supporting early design through execution for a large‑scale site expansion.

Key Responsibilities

Design Verification Program Leadership

• Develop, implement, and maintain the Design Verification (DV) framework for facilities, equipment, automation, utilities, and process changes
• Ensure alignment with GMP, ICH Q8–Q11, FDA, EMA, and ISPE Baseline Guide expectations
• Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments
• Serve as Technical Lead and Design Verification authority for assigned scopes supporting a new site build‑out

User Requirements & Functional Specifications

• Lead cross‑functional teams to translate process needs into clear, testable User Requirements Specifications (URS)
• Ensure requirements are traceable, risk‑based, and technically feasible
• Review and challenge vendor Functional Design Specifications (FDS), Detailed Design Specifications (DDS), P&IDs, and engineering deliverables line‑by‑line
• Support development of verification strategies aligned with commissioning and qualification plans

Design & Execution Support

• Provide hands‑on design verification support from pre‑conceptual design through detailed design and execution phases
• Lead and participate in P&ID design reviews, ensuring alignment with process intent, material flow, personnel flow, and warehouse logistics
• Apply change control strategies throughout execution phases of a new site build from a design perspective
• Partner with vendors to manage scope, quality expectations, schedules, and technical alignment
• Align design deliverables with FAT and SAT testing to ensure specifications meet site and regulatory expectations

Required Skills & Experience

• Extensive experience leading Design Verification activities for pharmaceutical manufacturing facilities
• Strong background in early‑phase design, detailed design, and pre‑conceptual design work
• Heavy P&ID experience, including hands‑on line‑by‑line design reviews
• Demonstrated ability to describe and execute design verification processes from start to finish
• Proven change control experience during execution phases of new site builds
• Experience with material flow, personnel flow, and warehouse material flow design
• Vendor management experience including scope control, schedule alignment, and quality oversight
• Strong knowledge of GMP regulations and lifecycle validation principles
• Ability to work cross‑functionally and lead technical discussions with engineering, quality, validation, and manufacturing teams

Preferred

• Pharmaceutical manufacturing experience
• New site expansion or greenfield project experience