Qualification and Validation Engineer (Pharmaceuticals) | Qualifizierungsingenieur / Validierungsingenieur / Pharmaingenieur (m/w/d)
ZwickRoell GmbH & Co. KG
Job Summary
As a Qualification and Validation Engineer at ZwickRoell, the global market leader in material testing systems, you will play a critical role in ensuring compliance for high-tech testing equipment. Your day-to-day responsibilities involve supporting customers with User Requirements Specifications (URS), conducting risk analyses, and managing qualification projects in accordance with cGMP and FDA regulations. You will be responsible for creating and verifying essential documentation for both standard and customized qualifications while providing technical guidance to service technicians. This role offers a high degree of autonomy and the opportunity to influence the development of the company's product portfolio. It is an ideal position for a detail-oriented professional who enjoys a mix of technical documentation, customer consulting, and occasional travel. ZwickRoell offers a modern family-owned environment with a 35-hour work week, flexible hours, and a strong focus on professional development.
Required Skills
Education
Degree in Engineering or Pharmacy (e.g., Pharmaceutical Technology, Medical Technology, Biotechnology, Mechanical Engineering, Mechatronics, Electronics) or a comparable qualification in the field of validation.
Experience
- Several years of professional experience in qualification and validation processes
- Proven experience in project management within a technical or pharmaceutical environment
- Extensive knowledge of regulatory requirements including cGMP and FDA standards
- Experience in creating and reviewing technical qualification documentation
- Professional experience in customer consulting and technical support
Languages
Additional
- Willingness to travel occasionally for customer site visits; Ability to work independently and manage projects autonomously; Position is based in Ulm with hybrid/home office options available.