Validation Area Specialist - Utilities
Novo Nordisk
August 12, 2026
Remote friendly (Clayton, NC)
United States
Operations
The Position
Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.
Essential Functions
- Prepare, execute, analyze data, and write reports for IV, OV & PV protocols
- Own Change Requests (CRs) related to project validation
- Perform compliance and technical reviews/approvals of protocols and protocol data
- Author project quality masterplans (PQMPs), validation plans (VPLs), and other validation documentation
- Author and execute assigned IV, OV & PV protocols; serve as a validation technical expert for new systems
- Ensure validation protocols align with local, corporate, and regulatory requirements
- Lead validation failure investigations and non-conformities using root cause analysis
- Create/modify validation procedures and configuration item lists (CILs)
- Write/review specifications, procedures, and supporting documents to maintain validated state
- Participate in FAT/SAT commissioning and transition into validation ownership
- Identify process improvements before change control during validation
- Provide budget oversight and contractor scheduling/oversight as needed
Qualifications
- Bachelor’s degree in Engineering, Computer Science, or applicable technical degree (or equivalent experience) required
- Master’s degree preferred
- 7+ years validation/quality experience in a pharmaceutical environment required
- Regulatory/industry standards experience required (e.g., 21 CFR Part 11, GAMP5, ISO, electronic records retention, CILs, FDA/ICH)
- Root-cause analysis experience preferred
- Technical documentation/procedures writing ability preferred
- Pharmaceutical manufacturing experience and GMP knowledge preferred
- Change management skills within Novo Nordisk preferred
Benefits (if offered)
- Leading pay and annual performance bonus; 14 paid holidays; health/dental/vision (day one)
- 8% 401(k) contribution (plus match); paid parental leave (14 weeks) and family medical leave (6 weeks); tuition assistance; life/disability insurance; free access to Novo Nordisk-marketed products; referral awards
Application Instructions
- For application accommodations, call 1-855-411-5290 (accommodation requests only).
Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.
Essential Functions
- Prepare, execute, analyze data, and write reports for IV, OV & PV protocols
- Own Change Requests (CRs) related to project validation
- Perform compliance and technical reviews/approvals of protocols and protocol data
- Author project quality masterplans (PQMPs), validation plans (VPLs), and other validation documentation
- Author and execute assigned IV, OV & PV protocols; serve as a validation technical expert for new systems
- Ensure validation protocols align with local, corporate, and regulatory requirements
- Lead validation failure investigations and non-conformities using root cause analysis
- Create/modify validation procedures and configuration item lists (CILs)
- Write/review specifications, procedures, and supporting documents to maintain validated state
- Participate in FAT/SAT commissioning and transition into validation ownership
- Identify process improvements before change control during validation
- Provide budget oversight and contractor scheduling/oversight as needed
Qualifications
- Bachelor’s degree in Engineering, Computer Science, or applicable technical degree (or equivalent experience) required
- Master’s degree preferred
- 7+ years validation/quality experience in a pharmaceutical environment required
- Regulatory/industry standards experience required (e.g., 21 CFR Part 11, GAMP5, ISO, electronic records retention, CILs, FDA/ICH)
- Root-cause analysis experience preferred
- Technical documentation/procedures writing ability preferred
- Pharmaceutical manufacturing experience and GMP knowledge preferred
- Change management skills within Novo Nordisk preferred
Benefits (if offered)
- Leading pay and annual performance bonus; 14 paid holidays; health/dental/vision (day one)
- 8% 401(k) contribution (plus match); paid parental leave (14 weeks) and family medical leave (6 weeks); tuition assistance; life/disability insurance; free access to Novo Nordisk-marketed products; referral awards
Application Instructions
- For application accommodations, call 1-855-411-5290 (accommodation requests only).