Lead Validation Specialist, IT & Automation (Pharma)

Novo Nordisk A/S; Clayton (NC); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Performance bonus

14 paid holidays

Health insurance

401K match

Parental leave

Product access

Job summary

Novo Nordisk is seeking a senior validation professional to lead IT & Automation validation efforts for FFEx projects in a GMP pharmaceutical environment. You will design, execute, and document validation activities across IV, OV, PV protocols and ensure regulatory compliance.

The role reports to Senior Project Manager, Site Capacity & Upfit, and requires strong leadership, project management, and root-cause analysis skills with experience in 21 CFR Part 11, GAMP5, and ISO standards.

Qualifications

• Bachelor's Degree in Engineering, Computer Science, or applicable technical degree required.
• Minimum of seven (7) years validation or quality related discipline experience in pharmaceutical environment.
• Experience with 21 CFR Part 11, GAMP5, ISO, FDA & ICH guidance documents.
• Ability to read, write & understand complicated product documentation.
• Demonstrated leadership & project management skills; ability to meet timelines and customer requirements.

Responsibilities

• Provide validation & technical support through preparation, execution, data analysis, and report writing for IV, OV & PV protocols.
• Own Change Requests related to project validation responsibilities.
• Perform compliance & technical reviews/approvals of protocols & data.
• Write/Review PQMPs, VPLs, and other validation documents.
• Lead validation activities for assigned systems and drive on-time delivery.

Skills

Root Cause Analysis

Project Management

Leadership

Regulatory Knowledge

Technical Documentation

Education

Bachelor's Degree in Engineering, Computer Science, or applicable technical degree

Master's Degree

Job description

Novo Nordisk is seeking a senior validation professional to lead IT & Automation validation efforts for FFEx projects in a GMP pharmaceutical environment. You will design, execute, and document validation activities across IV, OV, PV protocols and ensure regulatory compliance.

The role reports to Senior Project Manager, Site Capacity & Upfit, and requires strong leadership, project management, and root-cause analysis skills with experience in 21 CFR Part 11, GAMP5, and ISO standards.