Overview
Validation Engineer responsible for conducting and evolving process validation for pharmaceutical products (including vaccines) and drug substance at Takeda’s Singen site.
What you'll do
- Develop and define validation strategies for routine processes and project activities at the Singen location.
- Support documentation, execution, and evaluation of Aseptic Process Simulation (APS).
- Create, maintain, and release validation documentation under the Lifecycle Process Validation concept, including data analysis and reporting.
- Ensure alignment between manufacturing processes and performed validation activities.
- Conduct and support trainings for production and quality control staff on validation-related topics.
- Assess deviations, changes, and quality-relevant events for impact on validated process status and define required actions.
- Act as a Subject Matter Expert (SME) for process validation during inspections, audits, regulatory inquiries, and submission activities.
What you'll need
- Degree in biotechnology, pharmacy, biology, chemistry, process engineering, or a comparable qualification.
- Knowledge and practical experience in validation, with technical understanding of pharma manufacturing processes and GMP requirements.
- Independent, structured working style plus coordination and teamwork skills.
- Good IT skills.
- Analytical skills and high quality orientation.
- Communication and interface skills for working in an international environment.
- Very good German and English skills for communicating in both languages.
Details
- Location: Singen, Germany.
- Reports to: Head of Validation.
- Employment type: Full time (Regular employee).
Read the full description and apply on the company’s own careers page.
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