Process Validation Specialist

7 days ago


Singapur, Singapore Takeda Full time
About the Role:

The Process Validation Engineer will be responsible for providing process validation support for Takeda's vaccine manufacturing operations located in internal and CMO manufacturing locations. This includes overseeing process validation activities, developing and authoring process validation studies, and ensuring compilation of data and results into summary and final reports.

Key Responsibilities:
  • Develop and execute process validation strategies for vaccine manufacturing processes
  • Author and compile process validation studies and reports
  • Participate in regulatory inspections and ensure compliance with cGMP requirements
  • Identify opportunities for continuous improvements and implement best practices
  • Represent global validation for Vaccine Business Unit at project meetings and support/maintain process validation in various internal and external communication
Requirements:
  • Bachelor's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field with a minimum of 5 years relevant experience
  • Master's degree in related field with a minimum of 3 years relevant experience
  • PhD in related field with minimum of 0 years relevant experience
  • Previous experience developing validation strategies and implementing for projects
  • Knowledge of Lifecycle Validation stages and implementation
  • Understanding of cGMP requirements for validation documentation
  • Excellent written and verbal communication skills
Desired Skills:
  • Working knowledge of risk assessment methodologies and practices
  • Experience authoring and executing process validation studies for commercial GMP manufacturing processes
  • Familiarity with broad range of QC analytical test methods and analytical method development and capabilities
About Takeda:

Takeda is a patient-focused company that transforms patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. We are a global top employer that offers stimulating careers, encourages innovation, and strives for excellence in everything we do.



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