Lead CSV Engineer for GMP & GxP Validation
USWM, LLC
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Job summary
US WorldMeds seeks a Computer System Validation Engineer to ensure compliant validation of computerized systems across product development and manufacturing.
You will lead CSV activities, supervise validation teams, maintain SDLC documentation, and ensure GMP readiness, audit trails, and data integrity.
This role requires 5+ years in QA/CSV within biotech or pharma, strong communication, and collaboration with cross-functional partners.
Qualifications
- Bachelor’s degree in science or a related technical field.
- 5+ years in QA/validation for automation or computerized systems in biopharma.
- Strong knowledge of cGMP, guidance, and multinational regulations.
- Experience leading projects; capable of cross-functional collaboration.
- Familiarity with SDLC, validation docs, and change control processes.
Responsibilities
- Provide QA oversight for SDLC deliverables supporting GxP systems.
- Lead validation teams and define risk-based validation/testing approaches.
- Review protocol/discrepancies to ensure conformance with regulations.
- Ensure audit trails, access controls, and data integrity strategies.
- Support regulatory inspections and maintain inspection readiness.
- Collaborate with cross-functional teams on CAPA/Change Control.
Skills
Education
Tools
Job description
US WorldMeds seeks a Computer System Validation Engineer to ensure compliant validation of computerized systems across product development and manufacturing.
You will lead CSV activities, supervise validation teams, maintain SDLC documentation, and ensure GMP readiness, audit trails, and data integrity.
This role requires 5+ years in QA/CSV within biotech or pharma, strong communication, and collaboration with cross-functional partners.
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