Biotechnology, Biochemistry, or Packaging Engineer Specialist (Pharmaceuticals) | Biotechnologe (m/w/d) Biochemiker (m/w/d) Verpackungsingenieur (m/w/d)
agento PersonalManagement GmbH
Job Summary
This role involves supporting the Qualified Person (QP) for investigational medicinal products (IMPs) by providing procedural and administrative assistance within a leading global pharmaceutical company. The specialist will be responsible for meticulously reviewing the release documentation for IMPs, ensuring strict compliance with regulatory documentation (CTAA), current Good Manufacturing Practice (cGMP), and internal guidelines. Key responsibilities include documenting review results, monitoring associated KPIs, and actively contributing to the continuous improvement of the release process and related systems. The position requires strong knowledge of national and international regulatory requirements for clinical trials and IMPs, excellent communication skills for collaborating with internal and external stakeholders, and proficiency in IT systems. This is an attractive opportunity offering a challenging and responsible role with high potential for permanent employment and a hybrid work model.
Required Skills
Education
Master's degree in a scientific field of study (Biotechnology, Biochemistry, Pharmaceutical Engineering, or related); Alternatively, completed vocational training in the pharmaceutical environment.
Experience
- Mid-level professional experience in one or more of the following: Pharmaceutical Development, Manufacturing, Packaging, Testing, Clinical Trial Authorization, or Quality Assurance
- Multi-year, relevant professional experience in the pharmaceutical environment (alternative to Master's degree)
- Demonstrated ability to successfully, efficiently, and carefully process complex issues
Languages
Additional
- Located in Biberach; Position offers a hybrid work model (2-3 days remote/home office after initial on-site training); Unspecified contract duration with very good chance of permanent employment.
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