Pharma/Medical Device Design Verification Lead

PHARMA/MEDICAL DEVICE INDUSTRY EXPERIENCE IS MANDATORY

Overview

We are seeking an experienced Design Verification Lead to support a large-scale greenfield site expansion within a regulated pharmaceutical manufacturing environment. This role offers the opportunity to play a critical part in building a state-of-the-art facility from early concept through execution, working closely with cross-functional teams across engineering, quality, and manufacturing.

This position is ideal for professionals who thrive in complex build-out projects and want to drive design excellence, compliance, and operational readiness at a high-impact site.

Key Responsibilities

Design Verification Leadership

• Lead the development and execution of the Design Verification (DV) framework across facilities, equipment, utilities, and processes
• Ensure alignment with GMP, FDA, EMA, ICH (Q8–Q11), and ISPE guidelines
• Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments
• Serve as the technical authority for design verification activities within a major site build-out

Requirements & Specifications Management

• Partner with cross-functional teams to develop User Requirements Specifications (URS)
• Ensure all requirements are testable, traceable, and compliant
• Review and provide technical oversight on vendor documentation including FDS and DDS
• Support risk-based verification planning and commissioning strategies

Design & Engineering Oversight

• Review P&ID documentation in detail, including line-by-line analysis
• Provide expertise across early design, conceptual design, and detailed design phases
• Ensure design intent is maintained through execution and commissioning

Site Build & Execution Support

• Support greenfield site expansion activities including CAPEX-driven initiatives
• Contribute to material flow, personnel flow, and warehouse flow design strategies
• Lead design verification efforts throughout the full project lifecycle

Vendor & Stakeholder Management

• Collaborate with external vendors to ensure alignment on scope, quality, and technical deliverables
• Coordinate FAT and SAT schedules to ensure design alignment with site requirements
• Drive cross-functional collaboration between engineering, construction, validation, and quality teams

Change Control & Compliance

• Develop and implement change control strategies for design and execution phases
• Ensure all changes are documented, evaluated, and compliant with regulatory standards

Qualifications

Required

• Extensive experience in pharmaceutical or biotech manufacturing environments
• Proven background in design verification for capital projects, site expansions, or greenfield builds
• Strong expertise working with P&IDs and engineering design reviews
• Experience across early-phase and detailed design processes
• Demonstrated experience supporting site build-outs and construction collaboration
• Background working with both design and construction teams

Preferred

• Experience with CAPEX projects, site expansion, or new facility builds
• Knowledge of material flow, personnel flow, and warehouse design principles
• Strong vendor management experience including scope and quality alignment

Key Skills

• Design Verification Strategy & Execution
• GMP and Regulatory Compliance
• Engineering Design Review (P&ID, FDS, DDS)
• Cross-Functional Leadership
• Change Control Management
• Commissioning & Qualification Support

Why Join?

• Be part of a high-impact greenfield project shaping a new manufacturing facility
• Work in a highly collaborative environment with engineering, quality, and operations teams
• Gain exposure to the full lifecycle of a major capital project—from concept through execution
• Opportunity to lead and influence critical design decisions at scale