Sr Computer Systems Validation Analyst
Novo Nordisk
August 11, 2026
On-site
Clayton, NC
IT
The Position
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 relevant regulations and standards, enabling seamless project transition and handover to service operations.
Responsibilities
- Participate in IT solutions validation (IT Infrastructure, IT Systems, computerized equipment supporting labs, manufacturing, and business areas).
- Ensure IT solutions comply 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/OQ/PQ protocols, operating & maintenance instructions).
- Conduct risk assessments and impact analyses; develop mitigation strategies.
- Support project teams with validation/qualification requirements.
- Monitor and continuously improve CSV documentation/processes and identify efficiencies; stay informed of regulatory changes.
- Perform Quality Systems activities (document management, change control, deviations, CAPA).
- Write/revise CSV procedures; collaborate with Engineering on validation/requalification/maintenance programs.
- Facilitate handover to service operations; maintain documentation per Novo Nordisk and regulatory standards.
- Serve as CSV SME for audits/inspections; provide documentation to demonstrate validated state and release to use.
- Coordinate cross-functionally to deliver on time/in budget with proper documentation.
- Provide leadership/expertise in IT CSV and process improvement; coach/mentor personnel.
- Execute process improvement using cLEAN tools; manage deviations (document/investigate/resolve; assess and implement changes controlled).
- Develop and deliver CSV/process improvement training; communicate with stakeholders.
- Follow safety/environmental requirements; other duties as assigned.
Qualifications
- Bachelor’s degree in IT, Engineering, Science, or related field (required); Master’s preferred.
- 7+ years IT compliance experience (preferably pharma API/finish production manufacturing) (required).
- 5+ years validation/testing of IT solutions (required).
- Preferred: CSQE, COBIT, Lean Six Sigma (Green/Black Belt).
- Preferred: Electronic application lifecycle experience (requirements through testing/deployment; HP ALM preferred).
- Preferred: SME in audits/inspections; experience with GxP, change management, deviation handling; Incident/Problem/Change Mgmt in IT.
- Required: excellent English writing/communication; customer service; collaboration.
- Required: problem solving, negotiation, conflict management, interpersonal skills; planning/organizing/decision making; 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 relevant regulations and standards, enabling seamless project transition and handover to service operations.
Responsibilities
- Participate in IT solutions validation (IT Infrastructure, IT Systems, computerized equipment supporting labs, manufacturing, and business areas).
- Ensure IT solutions comply 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/OQ/PQ protocols, operating & maintenance instructions).
- Conduct risk assessments and impact analyses; develop mitigation strategies.
- Support project teams with validation/qualification requirements.
- Monitor and continuously improve CSV documentation/processes and identify efficiencies; stay informed of regulatory changes.
- Perform Quality Systems activities (document management, change control, deviations, CAPA).
- Write/revise CSV procedures; collaborate with Engineering on validation/requalification/maintenance programs.
- Facilitate handover to service operations; maintain documentation per Novo Nordisk and regulatory standards.
- Serve as CSV SME for audits/inspections; provide documentation to demonstrate validated state and release to use.
- Coordinate cross-functionally to deliver on time/in budget with proper documentation.
- Provide leadership/expertise in IT CSV and process improvement; coach/mentor personnel.
- Execute process improvement using cLEAN tools; manage deviations (document/investigate/resolve; assess and implement changes controlled).
- Develop and deliver CSV/process improvement training; communicate with stakeholders.
- Follow safety/environmental requirements; other duties as assigned.
Qualifications
- Bachelor’s degree in IT, Engineering, Science, or related field (required); Master’s preferred.
- 7+ years IT compliance experience (preferably pharma API/finish production manufacturing) (required).
- 5+ years validation/testing of IT solutions (required).
- Preferred: CSQE, COBIT, Lean Six Sigma (Green/Black Belt).
- Preferred: Electronic application lifecycle experience (requirements through testing/deployment; HP ALM preferred).
- Preferred: SME in audits/inspections; experience with GxP, change management, deviation handling; Incident/Problem/Change Mgmt in IT.
- Required: excellent English writing/communication; customer service; collaboration.
- Required: problem solving, negotiation, conflict management, interpersonal skills; planning/organizing/decision making; strong MS Office skills.