Qualification / Validation Engineer (m/f/d) | Qualifizierungsingenieur / Validierungsingenieur / Pharmaingenieur (m/w/d)
ZwickRoell GmbH & Co. KG
Job Summary
This role involves supporting customers with User Requirements Specification (URS) and conducting risk analyses. The engineer will manage qualification projects, provide expert advice on pharmaceutical industry requirements (cGMP/FDA), and create and review qualification-related documents for both basic and individual qualifications. A high degree of autonomy is granted in project implementation. The position also includes providing technical support to service technicians during qualification procedures and actively contributing to portfolio development and analysis. This is an attractive opportunity for an engineer with strong regulatory knowledge and project management skills to work in a modern family-owned company, offering a future-proof workplace and numerous development opportunities.
Required Skills
Education
Successfully completed degree in Engineering or Pharmacy (Pharmaceutical Technology, Medical Technology, Biotechnology, Mechanical Engineering, Mechatronics, Electronics, etc.) or comparable qualification in the qualification environment.
Experience
- Several years of professional experience with qualifications
- Several years of professional experience in project management
- Extensive knowledge of regulatory requirements for qualifications and computer validations (cGMP and FDA)
Languages
Additional
- Willingness for occasional travel