Lead Validation Engineer

Role: Lead Validation Engineer supporting GMP manufacturing, QC, facilities, and R&D operations for gene therapy products. Responsibilities: oversee qualification activities for equipment, utilities, and facilities; develop validation strategies using risk-based methodologies aligned with FDA, EU GMP, ISPE, and GAMP; author and review validation documentation; lead IQ, OQ, PQ, EMPQ, and utility qualification projects; ensure compliance, support audits, and drive continuous improvement. Requirements: Bachelor's in Engineering, Life Sciences, Biotechnology or related; 5+ years GMP validation experience in biotech, pharmaceutical, or gene therapy sectors; proven ability to manage complex validation projects independently. HighValue: expertise in equipment, utility, facility, and process qualification; experience with autoclaves, environmental monitoring, airflow studies, temperature mapping, and utility systems; familiarity with regulatory standards and validation lifecycle management; supporting R&D, manufacturing, and QC environments within regulated GMP settings. WorkSetup: on-site in Germantown, MD; occasional outside hours may be required.