Process Validation Engineer
3 weeks ago
About the Role:
The Process Validation Engineer will be responsible for providing process validation support for Takeda vaccines manufacturing operations located in internal and CMO manufacturing locations. This includes overseeing process validation activities, developing and authoring process validation strategies, and ensuring compliance with cGMP requirements.
Key Responsibilities:
- Develop and execute process validation studies and projects to enhance manufacturing systems and processes.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Technical Operation, to develop and execute process validation studies and projects.
- Ensure compliance with cGMP requirements and regulatory guidelines.
- Provide technical input to validation activities and represent process validation during tech transfer activities as required.
- Support process validation Quality Systems and identify opportunities for continuous improvements.
Requirements:
- Bachelor's in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field with a minimum of 5 years relevant experience.
- Master's 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 the Lifecycle Validation stages and further implementation.
- Understanding of cGMP requirements for validation documentation.
- Excellent written and verbal communication skills and demonstrated ability to collaborate with multiple functions to execute validation activities and incorporate validation results into routine operational practices.
About Takeda:
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
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