Validation Lead – Biopharma Process Excellence

Novartis; Malaysia; On-site; MYR 90,000 - 130,000; Full time

Job summary

Novartis Malaysia is seeking a Validation Lead to drive validation strategy and implementation across manufacturing operations in Selangor. You will lead cross-functional teams, coordinate validation activities, and ensure processes meet regulatory and quality requirements for global markets.

The role emphasizes lifecycle management, investigations into deviations, and continuous improvement of validation programs.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or a related field.
• 2–8 years of experience in biopharma or pharma manufacturing.
• Strong understanding of manufacturing processes and equipment.
• Knowledge of quality systems and regulatory requirements across health authorities.
• Experience validating processes and/or cleaning validation in regulated settings.
• Experience in technical report writing and cross-functional project management.

Responsibilities

• Develop validation documentation to support compliant manufacturing and lifecycle management.
• Execute process and cleaning validation strategies per regulatory and quality requirements.
• Coordinate validation activities with cross-functional teams for timely execution.
• Provide validation support for global manufacturing processes including Singapore ops.
• Lead investigations and resolve validation deviations, observations, and issues.
• Review and approve validation protocols, reports and risk assessments.
• Drive continuous improvement to enhance validation effectiveness and operations.
• Manage validation projects and stakeholder engagement across sites.

Skills

Applied Statistics

Manufacturing Production

Manufacturing Technologies

Operational Excellence

Process Control

Quality Compliance

Regulatory Compliance

Technical Leadership

Technology Transfer

Education

Bachelor’s or Master’s degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or related field

Job description

Novartis Malaysia is seeking a Validation Lead to drive validation strategy and implementation across manufacturing operations in Selangor. You will lead cross-functional teams, coordinate validation activities, and ensure processes meet regulatory and quality requirements for global markets.

The role emphasizes lifecycle management, investigations into deviations, and continuous improvement of validation programs.