Lead CSV Engineer - GxP Computer System Validation
US WorldMeds, LLC
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Descrizione del lavoro
US WorldMeds, LLC is seeking a Computer System Validation Engineer to assure the compliance and efficiency of computerized systems across the validation lifecycle. You will provide QA oversight on product, process, equipment, software, and facilities changes, ensuring validation activities align with US WorldMeds procedures and GxP regulations.
The role requires end-to-end CSV experience, regulatory familiarity with audit trails and access control, and collaboration across cross-functional teams
Competenze
- Bachelor’s degree in science or related technical field; 5+ years QA/validation in biotech/pharma.
- Experience with GMP, GAMP, ICH guidelines, and 21 CFR parts relevant to CSV/CSA.
Mansioni
- Provide QA oversight for SDLC deliverables supporting GxP operations.
- Lead validation activities and define risk-based approaches for computer system validation.
- Review validation records (URS, DQ, IQ/OQ/PQ) and ensure regulatory compliance.
- Support regulatory inspections and audits; ensure proper archival of SDLC deliverables.
Conoscenze
Formazione
Strumenti
Descrizione del lavoro
US WorldMeds, LLC is seeking a Computer System Validation Engineer to assure the compliance and efficiency of computerized systems across the validation lifecycle. You will provide QA oversight on product, process, equipment, software, and facilities changes, ensuring validation activities align with US WorldMeds procedures and GxP regulations.
The role requires end-to-end CSV experience, regulatory familiarity with audit trails and access control, and collaboration across cross-functional teams
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