Biotechnology Validation Specialist
2 weeks ago
About the Role:
The Process Validation Engineer will be responsible for providing process validation support for Takeda vaccines manufacturing operations. This includes overseeing process validation activities, developing and authoring strategies and documentation, and ensuring compliance with cGMP requirements.
Responsibilities:
- Oversight of Process Validation activities including development, facilitation and support of strategies of process validation and related activities/documentation for Drug Substance, Drug Product and Diluent manufacturing processes for Lifecycle Validation Stages.
- Authoring of process validation studies, as well as ensuring compilation of data and results into summary and final reports.
- Align manufacturing processes with executed validation
- Participate in regulatory inspections.
- Identify opportunities for continuous improvements, participate in the deployment of best practices, represent global validation for Vaccine Business Unit at project meetings and support/maintain the process validation in various internal and external communication, meetings, etc.
How you will contribute:
1. Oversight including developing, and authoring strategy and/or execution documents for Process Validation activities in the following areas:
- Tech transfer (new product introduction)
- Change management
- Continuous lifecycle management
2. Develop and assess the following Quality System elements for Process Validation:
- CAPAs
- Deviations
3. Participate and contribute in design, development, validation, and routine GMP activities:
- Provide technical input to validation activities
- Represent process validation during tech transfer activities as required.
- Represent process validation during site GMP activities and participate on cross-functional teams
- Support process validation Quality Systems
What we offer:
Estimated Salary:$120,000 - $180,000 per annum
This role is located in Singapore and requires travel to India manufacturing locations and other Vaccine manufacturing areas up to 1-2 times per year.
About us:
Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do.
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