Validation Lead

Biopharma Careers; Selangor; Hybrid; MYR 180,000 - 280,000; Full time

Job summary

Novartis in Selangor, Malaysia seeks a Validation Lead to drive validation strategy across global manufacturing operations, coordinating complex projects with cross-functional teams to ensure compliant processes meeting regulatory expectations.

The role emphasizes documentation, risk assessments, and continuous improvement, spanning process and cleaning validation, investigations, and stakeholder engagement across sites.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or a related field.
• 2–8 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.

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

Process validation

Cleaning validation

Technical report writing

Cross-functional management

Regulatory knowledge

Quality systems

Validation strategy

Stakeholder engagement

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biological Sciences

Master's degree in Chemical Engineering

Master's degree in related field

Tools

AI tools

Document management systems

Regulatory databases

Job description

#LI-HybridLocation: Selangor, MalaysiaRelocation 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.

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.