Senior Design Verification Lead – Drug Substance Manufacturing

Job Title : Senior Design Verification Lead – Drug Substance Manufacturing (New Site Build)Duration : 2 Year ContractLocation : Onsite in Lebanon, INInterview : 2 Virtual Interviews ( relocation candidates are okay)Visa : US Citizen only Preferred Pharma and Site Expansion experience Job description Heavy P&ID experience, work on P&ID design reviews, review P&ID’s line by line. Ability to describe design verification from start to finish.Experience with early design process, detail design experience and specific examples around detail design previous work. Ability to work pre-conceptual design experience is a must.Must have change control examples and strategies for execution phases of a new site build out from a design perspective.Previous experience with material flow, personnel flow and warehouse material flowMust have vendor experience, managing scope and quality expectations and technical alignment. Align schedules with FAT and SAT testing to ensure specs are in line with site team.Working examples of early design and detailed design experience Key Responsibilities 1. Design Verification Program LeadershipDevelop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes.Ensure alignment with GMP, ICH Q8–Q11, FDA, EMA, and ISPE Baseline Guide expectations for biologics manufacturing.Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments.Serve as a Technical Lead a design verification authority for designated scopes in support of a new site facility build out 2. User Requirements & Functional SpecificationsLead cross‑functional teams to translate process needs into User Requirements Specifications (URS).Ensure all requirements are testable, traceable, and technically feasible.Review and challenge vendor Functional Design Specs (FDS), Detailed Design Specs (DDS), and engineering documentation for completeness and compliance.Support the development of verification plans and protocols, with a focus on a risk-based design qualification and commissioning plan