Sr. Computer Systems Validation Engineer (Durham, NC) Ensure the development, implementation, validation, and qualification of all manufacturing equipment, systems, and processes utilized in the companys manufacturing, testing and pharmaceutical support services meet strict quality, safety, and regulatory standards including 21 CFR Part II and Data Integrity (FDA), and pharmaceutical GxP. Lead and serve on cross-functional teams, assist IT with infrastructure and computerized compliance and serve as the subject matter expert during audits and inspections. 90% on-site, remote allowed sometimes. 10-20%, domestic and regional travel required, for supporting validation efforts at other sites. Job Requirements: Masters or Bachelors degree in Engineering, Sciences, Bio-Medical Engineering or related field. Foreign equivalents accepted. 3 years experience (or 5 years with Bachelors degree) in a validating GxP pharmaceutical or biotechnology laboratory services, or pharmaceutical manufacturing environment. Must include some experience with: - Implementation of FDA regulations at 21 CFR, Part 11 - Validation of systems utilizing GAMP 5 - Systemic Data Integrity Remediation Engineering with ALCOA+ - Validation planning for enterprise software architecture - Validating Multi-Tenant & Segregated Software Environments - Maintenance of the validated state under GAMP 5 during data migrations for upgrades or decommissioning - Risk-Based Testing using Failure Modes and Effects Analysis - Cross functional collaboration with other departments to ensure seamless, audit-ready validation project completion. - Minitab Mail resume to: Alcami Carolinas Corporation, 2320 Scientific Park Dr, Wilmington NC 28405, Attn: HR.
