Validation Lead

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

Job Description Summary

#LI-Hybrid

Location: Selangor, Malaysia

Relocation Support: This role is based in Selangor, Malaysia. Novartis is unable to offer relocation support: please only apply if accessible.

Are you passionate about driving validation excellence in a highly regulated biopharmaceutical environment? As a Validation Lead, you will play a critical role in ensuring robust, compliant manufacturing processes that support the delivery of high-quality medicines to patients worldwide. Working across functions and global stakeholders, you will lead validation strategy execution, coordinate complex projects, and help shape the future of manufacturing operations while contributing to meaningful innovations that improve lives.

Job Description

• Developing validation documentation to support compliant manufacturing processes and lifecycle management.
• Executing process and cleaning validation strategies aligned with regulatory and quality requirements.
• Coordinating validation activities with cross-functional teams to ensure timely and effective execution.
• Providing validation support for manufacturing processes serving global markets, including Singapore-related operations.
• Leading investigations and supporting resolution of validation deviations, observations, and technical issues.
• Reviewing and approving validation protocols, reports, risk assessments, and related technical documentation.
• Driving continuous improvement initiatives to enhance validation effectiveness, compliance, and operational performance.
• Managing validation projects and stakeholder engagement across multiple functions and sites.

Essential Requirements

• Bachelor's or Master's degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or a related field.
• Two to eight years of experience within a biopharmaceutical or pharmaceutical manufacturing environment.
• Strong understanding of manufacturing processes and associated production equipment.
• In-depth knowledge of quality systems and regulatory requirements across multiple health authorities.
• Experience executing process validation and/or cleaning validation activities in a regulated environment.
• Demonstrated expertise in technical report writing, document review, and cross-functional project management.

Desirable Requirements

• Fundamental understanding of pharmaceutical analytical testing methods and laboratory practices.
• Fluency in Artificial Intelligence tools and technologies to support innovation and operational excellence.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired

• Applied Statistics
• Manufacturing Production
• Manufacturing Technologies
• Operational Excellence
• Process Control
• Quality Compliance
• Regulatory Compliance
• Technical Leadership
• Technology Transfer