Lead Computer System Validation & Quality Engineer

USWM, LLC; Central City (KY); On-site; USD 90,000 - 130,000; Full time

Job summary

US WorldMeds seeks a Computer System Validation Engineer to ensure CSV compliance for GMP systems, from patient journey capture to integration, and to oversee IT system quality in line with USWM’s practices. You will lead validation activities, drive risk-based testing, review and approve validation documents, ensure audit trails and access controls, and support regulatory inspections.

The role requires 5+ years in QA/validation in biotech/pharma, familiarity with cGMP, GAMP, ICH guidelines, and

Qualifications

• Bachelor’s degree in science or related technical field.
• Minimum of 5 years of QA/Validation experience in biotech or pharma.
• Understanding of cGMP, regulatory guidance, and biopharma regulations.
• Experience leading projects and cross-functional teams.
• Knowledge of GAMP, ICH guidelines, and 21 CFR parts relevant to CSV.

Responsibilities

• Provide QA oversight for SDLC deliverables supporting GxP operations.
• Lead validation activities, ensure risk-based testing and proper documentation.
• Review and approve validation records (URS, DQ, IQ/OQ, PQ).
• Ensure audit trails, access controls, and data integrity strategies.
• Support regulatory inspections and CAPA/change control processes.

Skills

Quality Assurance

CSV methodologies

GxP compliance

Regulatory guidance

Cross-functional collaboration

Leadership

Quality Risk Management

Education

Bachelor's Degree in Science or related technical field

Tools

Word

Excel

PowerPoint

Job description

US WorldMeds seeks a Computer System Validation Engineer to ensure CSV compliance for GMP systems, from patient journey capture to integration, and to oversee IT system quality in line with USWM’s practices. You will lead validation activities, drive risk-based testing, review and approve validation documents, ensure audit trails and access controls, and support regulatory inspections.

The role requires 5+ years in QA/validation in biotech/pharma, familiarity with cGMP, GAMP, ICH guidelines, and