Lead Validation Engineer

Scorpion Therapeutics; Germantown (MD); On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks a Lead Validation Engineer to support GMP manufacturing, QC, facilities and R&D operations for gene therapy products. You will oversee qualification activities for equipment, utilities and facilities, develop risk-based validation strategies, and author validation documentation.

Lead IQ/OQ/PQ/EMPQ and utility qualification projects while ensuring compliance and audit readiness.

Qualifications

• Bachelor's degree in engineering, life sciences, biotechnology or related field.
• 5+ years GMP validation experience in biotech/pharma or gene therapy.
• Ability to manage complex validation projects independently.

Responsibilities

• Oversee qualification activities for equipment, utilities and facilities.
• Develop validation strategies 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.

Skills

GMP validation

Risk-based methodologies

Documentation review

Audit support

Education

Bachelor's in Engineering/Life Sciences/Biotechnology

Job description

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.