Validation Lead – Manufacturing Excellence

About the role

Novartis is seeking a Validation Lead to drive validation excellence in a highly regulated biopharmaceutical environment. You will ensure robust, compliant manufacturing processes that support the delivery of high‑quality medicines worldwide.

Key responsibilities

• Develop and maintain validation documentation for process and cleaning validation aligned with regulatory and quality requirements.
• Coordinate validation activities across cross‑functional teams and multiple sites, including global and Singapore‑related operations.
• Lead investigations, resolve validation deviations, and approve protocols, reports, risk assessments, and related technical documents.
• Manage validation projects, drive continuous improvement, and engage stakeholders to enhance compliance and operational performance.

Required profile

• Bachelor's or Master's degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering or related field.
• 2–8 years of experience in biopharmaceutical or pharmaceutical manufacturing.
• Strong understanding of manufacturing processes, equipment, quality systems and regulatory requirements across multiple health authorities.
• Proven experience in process and/or cleaning validation in a regulated environment.

Required skills

• Process validation
• Cleaning validation
• Technical report writing and document review
• Cross‑functional project management
• Applied statistics
• Manufacturing production and technologies
• Operational excellence
• Process control
• Quality and regulatory compliance
• Technical leadership and technology transfer