Validation Lead

Novartis Corporation (M) Sdn Bhd; Selangor; On-site; MYR 90,000 - 130,000; Full time

Job summary

Novartis is seeking a Validation Specialist to develop and execute validation documentation and strategies for compliant manufacturing processes across global markets, including Singapore-related operations. The role emphasizes process and cleaning validation, cross-functional coordination, and timely execution.

You will review protocols and reports, lead investigations into deviations, and drive continuous improvement while ensuring adherence to quality systems and regulatory requirements

Qualifications

• 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.
• Fundamental understanding of pharmaceutical analytical testing methods and laboratory practices.
• Fluency in Artificial Intelligence 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

Technical report writing

Cross-functional collaboration

AI tools fluency

Pharma analytical methods

Laboratory practices

Education

Bachelor's or Master's in Chemistry/Biological Sciences/Pharmacy

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.
• 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.
• 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.

Unlock job insights

Hirer responsiveness Salary match Number of applicants

Pharmaceuticals, Biotechnology & Medical Devices More than 10,000 employees

With approximately 100 000 associates in 140 countries worldwide, Novartis associates share a vision of a better today and tomorrow for patients – a vision that drives our growth and success. The greatest job satisfaction for our associates is the knowledge that they improve the quality of life for patients with increasing precision and efficiency through breakthrough science and innovation.

Our performance-oriented culture and responsible approach attract top experts in all areas – research and development, marketing and sales, finance and administration. Our talented associates have made us a global leader in healthcare. Novartis is committed to rewarding the people who invest ideas and work in our company.

With approximately 100 000 associates in 140 countries worldwide, Novartis associates share a vision of a better today and tomorrow for patients – a vision that drives our growth and success. The greatest job satisfaction for our associates is the knowledge that they improve the quality of life for patients with increasing precision and efficiency through breakthrough science and innovation.

Our performance-oriented culture and responsible approach attract top experts in all areas – research and development, marketing and sales, finance and administration. Our talented associates have made us a global leader in healthcare. Novartis is committed to rewarding the people who invest ideas and work in our company.

Researching careers? Find all the information and tips you need on career advice.