Senior Validation Lead - GMP Biotech & Gene Therapy

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

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.