Sr Computer Systems Validation Analyst
Novo Nordisk
June 29, 2026
On-site
Clayton, NC
IT
The Position / Responsibilities
- Provide subject matter expertise in Computer Systems Validation (CSV), process improvement, and IT compliance service delivery management across the site.
- Ensure IT solutions are implemented and released to use in compliance with applicable regulations and standards; support seamless transition/handover of projects to service operations.
- Ensure governance and continuous improvement to support product quality, patient safety, and data integrity.
- Participate in IT solutions validation (IT Infrastructure, IT Systems, and computerized equipment) supporting Laboratories, Manufacturing, and Business Areas.
- Ensure compliance with regulations/standards (e.g., 21 CFR Part 11, EU Annex 11, GAMP).
- Facilitate/review/approve/develop validation deliverables (URS, DQ, FMEA, risk assessments, FAT/SAT, IQ/IOQ/OQ/PQ protocols, operating & maintenance instructions).
- Conduct risk assessments/impact analyses; develop mitigation strategies.
- Perform Quality Systems activities (document management, change control, deviations, CAPA) and write/revise CSV procedures.
- Collaborate with Engineering on validation/requalification/maintenance programs; maintain documentation per Novo Nordisk standards.
- Act as CSV SME for audits/inspections; collaborate cross-functionally to meet business needs, schedule, budget, and release requirements.
- Lead expertise in IT CSV, process improvement, and project coordination; coach/mentor personnel.
- Execute improvement using cLEAN tools; solve and manage deviations in a controlled manner; develop and deliver training.
- Communicate with stakeholders and perform other duties as assigned.
Qualifications / Requirements
- Bachelor’s degree in IT, Engineering, Science, or related field (required).
- Master’s degree (preferred).
- 7+ years IT compliance experience (preferably pharma API and/or finished production manufacturing) (required).
- 5+ years validation/testing of IT solutions (required).
- Excellent writing and communication skills in English (required).
- Excellent customer service, collaboration, problem solving, planning/organizing, and interpersonal skills (required).
Preferred Skills/Certifications
- CSQE, COBIT certification, Lean Six Sigma Green Belt/Black Belt.
- Experience with electronic application lifecycle software (e.g., HP ALM).
- SME experience in audits/inspections.
- GxP, change management, deviation handling; Incident/Problem/Change Management in IT.
- Strong MS Office skills.
- Provide subject matter expertise in Computer Systems Validation (CSV), process improvement, and IT compliance service delivery management across the site.
- Ensure IT solutions are implemented and released to use in compliance with applicable regulations and standards; support seamless transition/handover of projects to service operations.
- Ensure governance and continuous improvement to support product quality, patient safety, and data integrity.
- Participate in IT solutions validation (IT Infrastructure, IT Systems, and computerized equipment) supporting Laboratories, Manufacturing, and Business Areas.
- Ensure compliance with regulations/standards (e.g., 21 CFR Part 11, EU Annex 11, GAMP).
- Facilitate/review/approve/develop validation deliverables (URS, DQ, FMEA, risk assessments, FAT/SAT, IQ/IOQ/OQ/PQ protocols, operating & maintenance instructions).
- Conduct risk assessments/impact analyses; develop mitigation strategies.
- Perform Quality Systems activities (document management, change control, deviations, CAPA) and write/revise CSV procedures.
- Collaborate with Engineering on validation/requalification/maintenance programs; maintain documentation per Novo Nordisk standards.
- Act as CSV SME for audits/inspections; collaborate cross-functionally to meet business needs, schedule, budget, and release requirements.
- Lead expertise in IT CSV, process improvement, and project coordination; coach/mentor personnel.
- Execute improvement using cLEAN tools; solve and manage deviations in a controlled manner; develop and deliver training.
- Communicate with stakeholders and perform other duties as assigned.
Qualifications / Requirements
- Bachelor’s degree in IT, Engineering, Science, or related field (required).
- Master’s degree (preferred).
- 7+ years IT compliance experience (preferably pharma API and/or finished production manufacturing) (required).
- 5+ years validation/testing of IT solutions (required).
- Excellent writing and communication skills in English (required).
- Excellent customer service, collaboration, problem solving, planning/organizing, and interpersonal skills (required).
Preferred Skills/Certifications
- CSQE, COBIT certification, Lean Six Sigma Green Belt/Black Belt.
- Experience with electronic application lifecycle software (e.g., HP ALM).
- SME experience in audits/inspections.
- GxP, change management, deviation handling; Incident/Problem/Change Management in IT.
- Strong MS Office skills.