Validation Lead

About the role

Novartis is looking for a Validation Lead for its growing Morrisville site in North Carolina. You will drive the site's validation strategy across process, cleaning, packaging and ongoing verification activities, building and influencing validation programs from the ground up and contributing to product launches, technical transfers and regulatory readiness.

Key responsibilities

• Lead the site validation strategy across process, cleaning, packaging and ongoing process and cleaning verification.
• 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 on equipment, utilities, system and analytical method validation interfaces.
• Support product launches and technical transfers by defining robust validation approaches and delivering the required data.
• Represent the site during audits, inspections and validation governance activities.

Required profile

• 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 or quality in oral solid dosage pharmaceutical manufacturing.
• 5 years of experience executing process validation, including 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.
• Desirable: PhD in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology or equivalent.

Required skills

• Process and cleaning validation
• Applied statistics
• Change controls
• Data analytics and digital tools
• Good Manufacturing Practices (GMP)
• Quality and regulatory compliance

What we offer

• Expected salary of $126,000 to $234,000 per year, depending on skills and experience.
• Performance-based cash incentive and possible eligibility for annual equity awards.
• Health, life and disability benefits, 401(k) with company contribution and match.
• Vacation, personal days, holidays and other leaves.