Lead Validation Engineer
Listed on 2026-10-08
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering -
Engineering
Regulatory Compliance Specialist, Quality Engineering, Pharma Engineer
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.
High Value: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.
Work Setup:on-site in Germantown, MD; occasional outside hours may be required.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).