CSV Engineer: GMP Computer System Validation Lead

US WorldMeds, LLC; Philadelphia (Philadelphia County); On-site; USD 110,000 - 150,000; Full time

Job summary

US WorldMeds, LLC is seeking a Computer System Validation Engineer to support GxP operations through end-to-end CSV activities, from planning through remediation. The role requires strong QA oversight, regulatory knowledge, and experience with SDLC deliverables and data integrity, with a cross-functional collaboration focus.

As part of the Quality organization, you will ensure systems are fully validated and compliant, manage change controls, and assist regulatory inspections, with emphasis on

Qualifications

• Bachelor’s degree in science or related field.
• 5+ years QA/validation experience in biotech/pharma.
• Understanding of cGMPs, regulatory guidance, and multi-national biosafety regulations.
• Experience leading projects is beneficial.
• Knowledge of global regulatory requirements for GMP CSV systems.

Responsibilities

• Provide QA oversight for SDLC deliverables to support GxP operations.
• Lead validation teams and apply quality principles.
• Review GxP deliverables for compliance with criteria and regulations.
• Implement data integrity, audit trails, and access controls in systems.
• Ensure proper documentation archiving for regulatory inspection readiness.
• Support supplier quality management and vendor compliance.

Skills

Cross-functional teamwork

Regulatory compliance

Quality Assurance mindset

Documentation and records

Communication skills

Project coordination

Validation planning

Risk assessment (FMEA)

GxP knowledge

Attention to detail

Education

Bachelor’s degree in Science or related field

Tools

Veeva

StarLIMS

Calibration manager databases

Electronic Lab Notebooks

Job description

US WorldMeds, LLC is seeking a Computer System Validation Engineer to support GxP operations through end-to-end CSV activities, from planning through remediation. The role requires strong QA oversight, regulatory knowledge, and experience with SDLC deliverables and data integrity, with a cross-functional collaboration focus.

As part of the Quality organization, you will ensure systems are fully validated and compliant, manage change controls, and assist regulatory inspections, with emphasis on