Senior Computer Systems Validation Engineer

USWM, LLC; New York (NY); On-site; USD 100,000 - 160,000; Full time

Job summary

US WorldMeds seeks a Computer System Validation Engineer to drive CSV activities across patient journey capture, integration, and IT system quality compliance. You will lead validation teams, ensure documentation and audits meet GxP and regulatory expectations, and oversee SDLC deliverables with cross-functional partners.

The role requires 5+ years in QA/validation within biotech/pharma, strong knowledge of cGMPs, GAMP, ICH, and USP guidelines, and the ability to manage risk and drive continuous

Qualifications

• 5+ years QA/validation experience in biotech/pharma.
• Solid understanding of cGMPs and regulatory guidance.
• Experience with global GMP CSV/validation standards (GAMP, ICH, USP).
• Knowledge of Quality Risk Management and CAPA processes.
• Experience using quality systems for CSV/CSA activities.
• Ability to lead cross-functional teams and communicate clearly.

Responsibilities

• Provide QA support and oversight for SDLC deliverables in GxP ops.
• Collaborate on risk-based approaches for CSV activities and testing.
• Lead validation teams and promote best practices.
• Review SDLC deliverables for conformance to criteria and regs.
• Implement audit trails, access controls, and data integrity strategies.
• Support regulatory inspections and audit readiness.
• Coordinate with Supplier Quality Management for vendor compliance.

Skills

Quality Assurance

Validation leadership

Regulatory knowledge

Cross-functional teamwork

Documentation practices

Communication skills

GxP compliance

Education

Bachelor's Degree in Science

Tools

Veeva

StarLIMS

Pas-X

ELN

TempTale

MODA

Document Control Software

Job description

US WorldMeds seeks a Computer System Validation Engineer to drive CSV activities across patient journey capture, integration, and IT system quality compliance. You will lead validation teams, ensure documentation and audits meet GxP and regulatory expectations, and oversee SDLC deliverables with cross-functional partners.

The role requires 5+ years in QA/validation within biotech/pharma, strong knowledge of cGMPs, GAMP, ICH, and USP guidelines, and the ability to manage risk and drive continuous