Sr Computer Systems Validation Analyst
Novo Nordisk
3 hours ago
On-site
Clayton, NC
IT
Responsibilities:
- Provide subject matter expertise in Computer Systems Validation (CSV), process improvement, and IT compliance service delivery across the site.
- Ensure IT solutions are implemented and released for use in compliance with relevant regulations and standards; enable seamless project transition/handover to service operations.
- Participate in IT solutions validation for IT infrastructure, IT systems, and computerized equipment supporting labs, 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; provide guidance on validation/qualification requirements.
- Execute quality system activities (document management, change control, deviations, CAPA); write/revise CSV procedures.
- Maintain documentation/process in line with Novo Nordisk standards and regulatory requirements; act as CSV SME in audits/inspections.
- Collaborate cross-functionally to meet business needs, timelines, and budget; lead/expertise in IT CSV and project coordination.
- Coach/mentor personnel; contribute to process group activities; use cLEAN tools for visual management.
- Handle deviations and ensure controlled documentation, investigation, resolution, and impact assessment.
- Develop/deliver training; communicate CSV and improvement needs to stakeholders.
- Follow safety & environmental requirements; other assigned duties.
Qualifications:
- Bachelor’s degree in IT/Engineering/Science or relevant field (required); Master’s preferred.
- 7+ years IT compliance experience (preferably pharma API/finish production); 5+ years validation/testing of IT solutions (required).
- Preferred: CSQE; COBIT; Lean Six Sigma Green/Black Belt; experience with electronic application lifecycle software (HP ALM preferred); SME in audits/inspections; GxP, change management & deviation handling; IT incident/problem/change management.
Required skills:
- Excellent English writing and communication; customer service and team collaboration.
- Problem solving, negotiation/conflict management, interpersonal skills.
- Planning/organizing/decision making; strong MS Office skills.
Preferred skills:
- Experience with GxP, change management/deviations; Incident/Problem/Change Management in IT.
Benefits (explicitly stated):
- Leading pay and annual performance bonus; paid time off (14 paid holidays); health/dental/vision effective day one; 8% 401K + company match; 14 weeks paid parental and 6 weeks paid family medical leave; free access to Novo Nordisk-marketed products; tuition assistance; life & disability insurance; employee referral awards.
Application instructions:
- If you need accommodation to apply, call 1-855-411-5290 (accommodation requests only).
- Provide subject matter expertise in Computer Systems Validation (CSV), process improvement, and IT compliance service delivery across the site.
- Ensure IT solutions are implemented and released for use in compliance with relevant regulations and standards; enable seamless project transition/handover to service operations.
- Participate in IT solutions validation for IT infrastructure, IT systems, and computerized equipment supporting labs, 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; provide guidance on validation/qualification requirements.
- Execute quality system activities (document management, change control, deviations, CAPA); write/revise CSV procedures.
- Maintain documentation/process in line with Novo Nordisk standards and regulatory requirements; act as CSV SME in audits/inspections.
- Collaborate cross-functionally to meet business needs, timelines, and budget; lead/expertise in IT CSV and project coordination.
- Coach/mentor personnel; contribute to process group activities; use cLEAN tools for visual management.
- Handle deviations and ensure controlled documentation, investigation, resolution, and impact assessment.
- Develop/deliver training; communicate CSV and improvement needs to stakeholders.
- Follow safety & environmental requirements; other assigned duties.
Qualifications:
- Bachelor’s degree in IT/Engineering/Science or relevant field (required); Master’s preferred.
- 7+ years IT compliance experience (preferably pharma API/finish production); 5+ years validation/testing of IT solutions (required).
- Preferred: CSQE; COBIT; Lean Six Sigma Green/Black Belt; experience with electronic application lifecycle software (HP ALM preferred); SME in audits/inspections; GxP, change management & deviation handling; IT incident/problem/change management.
Required skills:
- Excellent English writing and communication; customer service and team collaboration.
- Problem solving, negotiation/conflict management, interpersonal skills.
- Planning/organizing/decision making; strong MS Office skills.
Preferred skills:
- Experience with GxP, change management/deviations; Incident/Problem/Change Management in IT.
Benefits (explicitly stated):
- Leading pay and annual performance bonus; paid time off (14 paid holidays); health/dental/vision effective day one; 8% 401K + company match; 14 weeks paid parental and 6 weeks paid family medical leave; free access to Novo Nordisk-marketed products; tuition assistance; life & disability insurance; employee referral awards.
Application instructions:
- If you need accommodation to apply, call 1-855-411-5290 (accommodation requests only).