Validation Lead

Novartis Malaysia; Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

Novartis Malaysia is seeking a Validation Lead based in Selangor to drive validation strategy and ensure compliant manufacturing processes for global medicines. You will coordinate across functions and global stakeholders to deliver robust validation programs.

You will lead investigations, review protocols and reports, and push continuous improvement across sites, supporting Singapore-related operations and complex projects in a highly regulated biopharma environment.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or a related field.
• 2–8 years of experience in 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.
• Fundamental understanding of pharmaceutical analytical testing methods and laboratory practices.
• Fluency in AI tools and technologies to support innovation and operational excellence.

Responsibilities

• 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.

Skills

Validation leadership

Regulatory compliance

Process validation

Cross-functional PM

Education

Bachelor's or Master's degree in Chemistry,Biology, Pharmacy or Chemical Engineering

Tools

Quality systems

Job description

Summary

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.

About The Role

Key Responsibilities

• 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.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

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