Senior CSV Engineer: Computer System Validation

USWM, LLC; Philadelphia (Philadelphia County); On-site; USD 115,000 - 160,000; Full time

Job summary

US WorldMeds seeks a Computer System Validation Engineer to ensure compliant validation of computerized systems across GMP operations, from SDLC to QA oversight. You will lead validation teams, apply quality principles, and manage documentation and audits.

You will work with cross-functional teams to implement risk-based validation strategies, ensure data integrity, and support regulatory inspections while maintaining change control and CAPA processes.

Qualifications

• Bachelor’s degree in science or related technical field.
• 5+ years QA/Validation experience in biotech/pharma.
• Knowledge of cGMPs, regulatory guidance, and multi-national biopharma regulations.
• Experience leading projects and cross-functional teams.
• Familiarity with regulatory requirements for CSV/CSA activities (GAMP, ASTM-E2500, ICH, USP, 21 CFR 210/211/11).
• Ability to manage risk and ensure data integrity.

Responsibilities

• Provide QA oversight for SDLC deliverables supporting GxP operations.
• Collaborate with cross-functional teams to define risk-based CSV approaches.
• Lead validation teams and promote best practices in quality principles.
• Review GxP deliverables for SDLC compliance and regulatory criteria.
• Ensure audit trails, access controls, and data integrity strategies are implemented.
• Archive SDLC documents and ensure readiness for regulatory inspections.
• Coordinate with Quality and Supplier Quality on vendor compliance.

Skills

QA/CSV

GxP

Regulatory knowledge

Cross-functional teamwork

Documentation

Process improvement

GAMP/ICH guidelines

Communication

Project leadership

Quality risk management

Education

Bachelor’s Degree in Science or related field

Tools

Veeva

StarLIMS

Kaye

TempTale

ELN/Document Control Software

Job description

US WorldMeds seeks a Computer System Validation Engineer to ensure compliant validation of computerized systems across GMP operations, from SDLC to QA oversight. You will lead validation teams, apply quality principles, and manage documentation and audits.

You will work with cross-functional teams to implement risk-based validation strategies, ensure data integrity, and support regulatory inspections while maintaining change control and CAPA processes.