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Computer System Validation Engineer
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- The role partners cross-functionally at the site to create, administer, and improve computerized system validation deliverables to maintain data integrity, supporting ALCOA+ principles throughout the CSV lifecycle.
- Collaborate to develop, maintain, and improve validation master plans, CSV protocols, reports, risk assessments, gap analyses, traceability matrices, SOPs, and other validation documents for the Aprecia site.
- Perform testing of computerized systems, such as laboratory information management systems (LIMS), manufacturing execution systems (MES), enterprise resource planning (ERP), building automation systems (BAS), and electronic batch records (EBR) using manual or automated methods.
- Author cover/gap protocols for vendor supplied Commissioning & Qualification documents and provide oversight for vendor executed test scripts.
- Monitor and audit the performance, compliance, and data integrity of the computerized systems on a periodic basis.
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