About the role
Summary
Location: Morrisville, North Carolina
Join Novartis and play a pivotal role in shaping the future of pharmaceutical manufacturing at our growing Morrisville site. As the Validation Lead, you will drive the site’s validation strategy across process, cleaning, packaging, and ongoing verification activities, ensuring products are delivered with the highest standards of quality, compliance, and patient safety. This is a unique opportunity to build and influence validation programs from the ground up, partner with cross-functional experts, and contribute directly to successful product launches, technical transfers, and regulatory readiness in a dynamic and innovative manufacturing environment.
Key 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 the interfaces to equipment qualification / utilities qualification, system qualification, 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.
Essential Requirements
- 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.
Desirable Requirements
- PhD Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent.