Associate Director, Validation

Role: Associate Director of Validation leading validation strategies for process performance, lifecycle, shipping, and packaging validation in ophthalmic biopharma manufacturing. Responsibilities: develop and execute validation plans, protocols, and risk assessments; oversee PPQ campaigns, continuous process verification, and cold chain shipping validation; serve as SME during inspections and audits; manage validation resources and drive continuous improvement. Requirements: Bachelor’s in Engineering, Pharmaceutical Sciences, Chemistry, or related; 12+ years in pharma/biotech manufacturing with significant validation expertise; strong knowledge of Process Validation, cGMP, FDA/ICH standards, and validation lifecycle principles; experience in Cold Chain Shipping and Packaging Validation preferred. HighValue: ophthalmic drug/device manufacturing, process validation, lifecycle validation, cold chain shipping, cGMP compliance, regulatory inspection support. WorkSetup: not specified; senior leadership role.