Validation Area Specialist - Finished Production
Novo Nordisk
June 28, 2026
On-site
Clayton, NC
Operations
What We Offer You
- Leading pay and annual performance bonus for all positions
- Generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
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 related to project validation responsibilities
- Perform compliance & technical reviews/approvals of protocols and protocol data
- Author PQMPs, VPLs, and other validation documentation
- Author and execute assigned IV, OV & PV protocols for direct impact systems/processes
- Ensure validation compliance with local, corporate & regulatory requirements
- Lead validation failure investigations/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 to validation ownership for equipment
- Identify process improvements before change control during validation
- Provide budget oversight and contractor scheduling/oversight as needed
- Lead validation activities assigned by overall project manager
Qualifications
- Bachelor’s degree in Engineering, Computer Science, or applicable technical degree or equivalent work experience required
- Master’s degree preferred
- 7+ years validation or quality-related experience in a pharmaceutical environment required
- Experience with 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration item lists, FDA & ICH guidance required
Preferred Skills/Experience
- Root-cause analysis experience
- Ability to read/write complex product documentation
- Leadership and project management skills; ability to manage timelines and stakeholders
- Ability to write technical documentation from equipment manuals
- Pharmaceutical manufacturing and GMP knowledge
- Change management skills
Application Instructions
- If you need special assistance/accommodation to apply, call 1-855-411-5290 (accommodation requests only).
- Leading pay and annual performance bonus for all positions
- Generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
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 related to project validation responsibilities
- Perform compliance & technical reviews/approvals of protocols and protocol data
- Author PQMPs, VPLs, and other validation documentation
- Author and execute assigned IV, OV & PV protocols for direct impact systems/processes
- Ensure validation compliance with local, corporate & regulatory requirements
- Lead validation failure investigations/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 to validation ownership for equipment
- Identify process improvements before change control during validation
- Provide budget oversight and contractor scheduling/oversight as needed
- Lead validation activities assigned by overall project manager
Qualifications
- Bachelor’s degree in Engineering, Computer Science, or applicable technical degree or equivalent work experience required
- Master’s degree preferred
- 7+ years validation or quality-related experience in a pharmaceutical environment required
- Experience with 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration item lists, FDA & ICH guidance required
Preferred Skills/Experience
- Root-cause analysis experience
- Ability to read/write complex product documentation
- Leadership and project management skills; ability to manage timelines and stakeholders
- Ability to write technical documentation from equipment manuals
- Pharmaceutical manufacturing and GMP knowledge
- Change management skills
Application Instructions
- If you need special assistance/accommodation to apply, call 1-855-411-5290 (accommodation requests only).