Senior Validation Lead – IT & Automation Systems

BioSpace; Clayton (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Paid holidays & PTO

Job summary

Novo Nordisk is seeking a senior validation professional to provide/lead validation services for IT and automation projects across aseptic production and related facilities. The role reports to a Senior Project Manager and requires hands-on protocol execution, document creation, and cross-functional leadership.

Ideal candidates will have 7+ years in pharma validation, strong regulatory knowledge (21 CFR Part 11, GAMP5, ISO), and proven leadership in complex projects with multiple stakeholders.

Qualifications

• Bachelor's degree in engineering, computer science, or an equivalent technical field.
• 7+ years of validation or quality-related experience in pharmaceutical environments.
• Experience with 21 CFR Part 11, GAMP5, ISO, electronic records, and FDA/ICH guidance.
• Proven leadership, project management, and cross-functional collaboration.
• Ability to produce technical documentation and validation records.

Responsibilities

• Provide validation and technical support through IV, OV, PV protocols.
• Own change requests related to validation responsibilities.
• Perform compliance reviews and approvals of validation documentation.
• Author PQMPs, VPLs, and other validation documents.
• Lead validation activities for assigned systems and ensure timelines.
• Identify process improvements before change control.
• Mentor and act as subject-matter expert in validation.

Education

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

Master's Degree (preferred)

Leadership & project management

Root cause analysis

Regulatory & GMP knowledge

Excellent communication & collaboration

Job description

Novo Nordisk is seeking a senior validation professional to provide/lead validation services for IT and automation projects across aseptic production and related facilities. The role reports to a Senior Project Manager and requires hands-on protocol execution, document creation, and cross-functional leadership.

Ideal candidates will have 7+ years in pharma validation, strong regulatory knowledge (21 CFR Part 11, GAMP5, ISO), and proven leadership in complex projects with multiple stakeholders.