Design Verification Lead

United Consulting Hub

United States

United States

À propos

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

United States

Compétences linguistiques

English

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