Validation Lead

MY01 (FCRS = MY001) Novartis Corporation (Malaysia) Sdn. Bhd. (19710100054); Selangor; On-site; MYR 180,000 - 240,000; Full time

Job summary

Novartis, based in Selangor, Malaysia, is seeking a Validation Lead to drive robust validation strategies across manufacturing operations. You will coordinate cross‑functional teams and global stakeholders to ensure compliant processes and lifecycle management for high‑quality medicines.

The role emphasizes leading investigations, approving critical documentation, and advancing continuous improvement initiatives within a regulated environment.

Qualifications

• 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.

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.

Education

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

Two to eight years of experience in biopharmaceutical or pharmaceutical manufacturing

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.

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 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.

Skills Desired

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

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.

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together.