Biotechnology Engineer | Ingenieur/in - Biotechnologie
Takeda Austria GmbH
Job Summary
As a Biotechnology Engineer, you will take holistic responsibility for analytical methods and functional testing within the Manufacturing Science Laboratory, specifically for combination products. Your day-to-day work involves developing, validating, and optimizing analytical methods such as bioassays, chemical-physical tests, and functional tests like glide force and injection time. You will oversee the entire method lifecycle, from feasibility studies to method transfers into quality control, while ensuring strict adherence to GMP standards. You will act as a key interface between departments like Quality Assurance, Production, and external stakeholders to manage changes, deviations, and CAPAs. This role is ideal for a detail-oriented professional who enjoys troubleshooting technical challenges and maintaining high-quality documentation in a regulated pharmaceutical environment. The position offers a unique opportunity to work within an international company, gaining deep insights into pharmaceutical production and product development processes.
Required Skills
Education
Completed university degree (Bachelor or Master) in Biotechnology, Molecular Biology, Chemistry, Biomedical Sciences, or a comparable field.
Experience
- Several years of professional experience in a GMP-regulated laboratory environment
- Experience with bioassays and functional test systems
- Experience in method validation and verification
- Experience in performing CCIT or comparable integrity tests
- Experience in creating and maintaining GMP-compliant laboratory documentation
Languages
Additional
- Must be eligible to work in the location. Position requires strict adherence to GMP regulations and data integrity standards.