Sr Computer Systems Validation Analyst

Role: IT CSV Subject Matter Expert supporting pharmaceutical manufacturing at Novo Nordisk's NC API facility. Objectives include ensuring validation, compliance, and continuous improvement of IT solutions supporting labs, manufacturing, and business functions. Responsibilities encompass participating in validation activities for infrastructure and systems, maintaining regulatory compliance (e.g., 21 CFR Part 11, EU Annex 11, GAMP), conducting risk assessments, guiding project teams, and facilitating smooth project handovers. Additional duties involve handling deviations, audit support, documentation management, process improvements, and training delivery. Requirements: Bachelor's in IT, Engineering, Science or related field; 7+ years in IT compliance within pharma, with 5+ years in validation/testing of IT solutions; strong knowledge of GxP, change management, and GAMP standards. Preferred: Master’s degree, certifications (CSQE, COBIT, Lean Six Sigma), experience with lifecycle software like HP ALM, and familiarity with audits and inspections. HighValue: role focuses on GxP compliance, validation of IT infrastructure and systems in a pharmaceutical API setting, supporting manufacturing and quality operations. Collaboration with cross-functional teams, including engineering and quality, is essential. Work setup: onsite at NC facility with up to 10% travel.