Manager/Senior Manager, Process and Cleaning Validation

Role: Manage and lead process and cleaning validation programs for biopharmaceutical manufacturing, supporting early-stage process validation strategies. Responsibilities: develop validation master plans, protocols, and reports; conduct risk assessments and gap analyses; evaluate equipment and process procedures; support regulatory submissions and inspection readiness; train personnel; author and review validation documentation; oversee 3-5 validation team members including contractors; escalate technical or schedule issues. Requirements: Bachelor's in Engineering, Chemistry, or related; 8+ years supporting biopharma manufacturing validation, with experience in process validation, cleaning validation, or process engineering; strong project management and technical documentation skills; team leadership experience. Preferred: experience with LNP processes/equipment; knowledge of FDA, EMA, ICH validation guidelines; understanding of process design, CIP/COP systems, and analytical validation; familiarity with statistical validation methods; proficiency with Smartsheets. Travel: up to 25%. Work setup not specified.