Lead Validation Specialist – IT & Automation (Pharma)

Novo Nordisk; Clayton (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

401K match

Paid time off

Tuition Assistance

Life & Disability Insurance

Job summary

Novo Nordisk is seeking a senior validation professional to lead validation activities for IT and automation projects within aseptic and solid dosage facilities. This role reports to the Senior Project Manager, Site Capacity & Upfit, and requires coordinating with multiple sites globally.

You will own validation plans, execute complex protocols, and ensure compliance with 21 CFR Part 11, GAMP5, and GMP standards while driving continuous process improvements and timely project delivery.

Qualifications

• Bachelor's degree in engineering, computer science or related technical field.
• Minimum 7 years of validation or quality experience in pharma/manufacturing.
• Experience with regulatory requirements (GMP/ICH) and industry standards.

Responsibilities

• Provide validation & technical support through preparation, execution, data analysis, and report writing for IV, OV, PV protocols.
• Own Change Requests related to validation responsibilities.
• Perform reviews/approvals of protocols and data for compliance and technical accuracy.
• Author PQMPs, VPLs and other validation documentation to maintain validated state.

Skills

Validation

Quality compliance

Project management

Root-cause analysis

GxP knowledge

Education

Bachelor's Degree in Engineering

Master's Degree preferred

Tools

21 CFR Part 11

GAMP5

ISO standards

Job description

Novo Nordisk is seeking a senior validation professional to lead validation activities for IT and automation projects within aseptic and solid dosage facilities. This role reports to the Senior Project Manager, Site Capacity & Upfit, and requires coordinating with multiple sites globally.

You will own validation plans, execute complex protocols, and ensure compliance with 21 CFR Part 11, GAMP5, and GMP standards while driving continuous process improvements and timely project delivery.