Validation Lead — Process, Cleaning & Packaging Strategy

Novartis Group Companies; Durham (NC); On-site; USD 126,000 - 234,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Generous vacation and leave

Job summary

Novartis Group of Companies is seeking a Validation Lead in Morrisville, NC to shape the site's validation strategy across process, cleaning, packaging, and ongoing verification activities. You will own the Validation Master Plan, deliver robust data for product launches, and partner across Engineering, Quality, and IT to ensure compliance and patient safety.

This role requires 8+ years in pharmaceutical manufacturing with proven leadership in process validation, cleaning validation, and ongoing

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or a related scientific discipline.
• 8 years of experience in manufacturing / manufacturing science and technology / technical development / quality in oral solid dosage pharmaceutical manufacturing.
• 5 years of experience executing process validation, including experience leading and managing validation projects.
• Proven expertise leading process validation, cleaning validation, and ongoing process verification programs.
• Strong knowledge of quality systems, applied statistics, and global regulatory requirements.
• Demonstrated success managing complex cross‑functional projects and authoring technical validation documentation.

Responsibilities

• Lead the site validation strategy across process, cleaning, packaging, and ongoing process and cleaning verification activities.
• Own and maintain the Validation Master Plan, ensuring timely execution and inspection readiness.
• Establish, monitor, and improve validation performance metrics to support compliance and operational excellence.
• Provide technical leadership for validation risk assessments, investigations, and complex validation challenges.
• Partner with Engineering, Quality, Analytical Science & Technology, and IT to define interfaces to equipment qualification, utilities qualification, system qualification, and analytical method validation.
• Support product launches and technical transfers by defining robust validation approaches and delivering required data.
• Represent the site during audits, inspections, and validation governance activities while maintaining compliance standards.

Skills

Applied Statistics

Change Controls

Data Analytics

GMP

Manufacturing Processes

Manufacturing Production

Manufacturing Technologies

Operational Excellence

Process and Cleaning Validation

Process Control

Quality Compliance

Regulatory Compliance

Risk Management

Technical Leadership

Technology Transfer

Education

Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or related scientific discipline

PhD in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent

Job description

Novartis Group of Companies is seeking a Validation Lead in Morrisville, NC to shape the site's validation strategy across process, cleaning, packaging, and ongoing verification activities. You will own the Validation Master Plan, deliver robust data for product launches, and partner across Engineering, Quality, and IT to ensure compliance and patient safety.

This role requires 8+ years in pharmaceutical manufacturing with proven leadership in process validation, cleaning validation, and ongoing