Validation Lead - Hybrid Biopharma Quality & Compliance

Novartis; Selangor; Hybrid; MYR 180,000 - 240,000; Full time

Job summary

Novartis is seeking a Validation Lead in Selangor, Malaysia, Hybrid work model. You will drive validation strategy, coordinate cross-functional projects, and ensure compliant manufacturing processes that deliver high-quality medicines.

The role involves global collaboration across sites, including Singapore, with emphasis on investigations and continuous improvement. The candidate will have 2–8 years in biopharma manufacturing, strong technical writing skills, and solid knowledge of regulatory

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biological Sciences, Pharmacy, Chemical Engineering, or a related field.
• 2–8 years of experience in biopharmaceutical or pharmaceutical manufacturing.
• Strong understanding of manufacturing processes and production equipment.
• In-depth knowledge of quality systems and regulatory requirements across multiple health authorities.
• Experience executing process validation and/or cleaning validation in a regulated environment.
• Proven report writing, document review, and cross-functional project management capabilities.

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 for timely execution.
• Providing validation support for manufacturing processes serving global markets, including Singapore-related operations.
• Leading investigations and supporting resolution of deviations, observations, and technical issues.
• Reviewing and approving validation protocols, reports, risk assessments, and related docs.
• Driving continuous improvement to enhance validation effectiveness, compliance, and operations.
• Managing validation projects and stakeholder engagement across multiple functions and sites.

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

Job description

Novartis is seeking a Validation Lead in Selangor, Malaysia, Hybrid work model. You will drive validation strategy, coordinate cross-functional projects, and ensure compliant manufacturing processes that deliver high-quality medicines.

The role involves global collaboration across sites, including Singapore, with emphasis on investigations and continuous improvement. The candidate will have 2–8 years in biopharma manufacturing, strong technical writing skills, and solid knowledge of regulatory