Biopharma Validation Lead: Process & Compliance

Novartis; Selangor; Hybrid; MYR 120,000 - 210,000; Full time

Job summary

Novartis in Selangor, Malaysia, seeks a Validation Lead to drive validation strategy and execute cross-functional projects in a highly regulated biopharmaceutical environment. You will coordinate validation activities, develop robust documentation, and lead investigations to resolve deviations, ensuring compliant manufacturing for global markets.

The role emphasizes technical leadership, cross-team collaboration, and continuous improvement across sites, with hybrid work arrangements and a focus

Qualifications

• Bachelor's or Master's degree required in a relevant field.
• 2-8 years of biopharma/pharma manufacturing experience.
• Strong understanding of manufacturing processes and equipment.
• Knowledge of quality systems and regulatory requirements across health authorities.
• Experience validating processes and/or cleaning in regulated environments.
• Proven skills in technical reporting, document review, and cross-functional project management.

Responsibilities

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

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

Tools

Artificial Intelligence tools

Job description

Novartis in Selangor, Malaysia, seeks a Validation Lead to drive validation strategy and execute cross-functional projects in a highly regulated biopharmaceutical environment. You will coordinate validation activities, develop robust documentation, and lead investigations to resolve deviations, ensuring compliant manufacturing for global markets.

The role emphasizes technical leadership, cross-team collaboration, and continuous improvement across sites, with hybrid work arrangements and a focus