Validation Lead

Responsibilities:Lead validation activities for equipment, utilities, facilities, and manufacturing systems within regulated environments.Develop validation strategies and lifecycle plans aligned with project and quality objectives.Author, review, and approve validation documentation including IQ, OQ, and PQ protocols and summary reports.Coordinate execution efforts across engineering, quality, manufacturing, and external vendors.Track validation deliverables against project timelines and provide routine status updates to leadership.Support commissioning and system start-up activities to ensure readiness for qualification.Identify and resolve deviations, discrepancies, and documentation gaps in accordance with quality systems.Ensure compliance with GMP standards and regulatory expectations.Support audit and inspection readiness by maintaining organized and accurate validation records.Promote safe execution practices and structured documentation standards.Requirements:Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.5+ years of validation experience in a regulated manufacturing environment.Strong knowledge of validation lifecycle principles and documentation practices.Experience executing equipment, utility, facility, or process validation.Working knowledge of GMP and regulatory compliance standards.Ability to manage multiple validation activities simultaneously in a fast-paced setting.Strong technical writing and document review skills.Effective communication and collaboration skills across cross-functional teams.On-site availability in Indianapolis, IN.Pharmaceutical, biotech, or medical device experience preferred.