Biotechnology Validation Specialist
6 days ago
About the Role:
The Process Validation Engineer will provide process validation support for Takeda's vaccine manufacturing operations in internal and contract manufacturing locations.
Responsibilities
- Develop, facilitate, and support process validation strategies and related activities/documentation for drug substance, drug product, and diluent manufacturing processes across lifecycle validation stages.
- Author and compile process validation studies, reports, and data to ensure compliance with regulatory requirements.
- Align manufacturing processes with executed validation and participate in regulatory inspections.
- Identify opportunities for continuous improvement and deploy best practices within the organization.
Your Contributions:
As a Process Validation Engineer, you will develop and author strategy and execution documents for process validation activities in tech transfer, change management, and continuous lifecycle management.
You will also assess quality system elements for process validation, including CAPAs and deviations, and participate in design, development, validation, and routine GMP activities.
In this role, you will represent process validation during tech transfer activities, site GMP activities, and cross-functional teams.
Requirements
- A bachelor's degree in chemical, biochemical, bioprocess engineering, chemistry, biochemistry, or a related field with a minimum of 5 years of relevant experience.
- Master's degree in a related field with a minimum of 3 years of relevant experience.
- PhD in a related field with minimal experience.
- Prior experience developing validation strategies and implementing for projects is required.
- Knowledge of lifecycle validation stages, cGMP requirements, and drug substance, drug product manufacturing is essential.
- Excellent written and verbal communication skills are necessary for collaboration with multiple functions.
Preferred Qualifications
- Working knowledge of risk assessment methodologies and established risk analyses for testing strategy development and justification.
- Experience authoring and executing process validation studies for commercial GMP manufacturing processes, including process qualification and supporting studies.
- Familiarity with broad QC analytical test methods and method development capabilities.
Salary Range: $100,000 - $120,000 per year (dependent on location and experience).
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