Qualification and Validation Engineer / Technician | Ingenieur/Techniker Qualifizierung/Validierung (m/w/d)
Vetter Pharma Fertigung GmbH & Co. KG
Job Summary
This role at Vetter, a leading global pharmaceutical service provider, focuses on ensuring the integrity of aseptic production environments through rigorous qualification and validation processes. You will be responsible for conducting and documenting 'Smoke Studies' using video technology to visualize airflow, interpreting results alongside Production and Quality Assurance teams. Beyond these specialized studies, you will manage classic validation projects for complex technical systems, machinery, and pharmaceutical cleanrooms. The position involves creating risk analyses, executing test plans, and generating GMP-compliant reports for regulatory evidence. As a subject matter expert, you will act as a key point of contact for external suppliers and internal stakeholders during new equipment installations or system modifications, ensuring all technical requirements meet stringent pharmaceutical standards. This is an excellent opportunity for a detail-oriented professional to contribute to the production of life-saving medications in a modern, family-owned corporate environment.
Required Skills
Education
Technical/Scientific degree or a Technician certification; relevant practical experience in aseptic manufacturing may be accepted in lieu of a specific degree.
Experience
- Professional experience in pharmaceutical production, specifically within aseptic filling environments
- Experience in conducting and documenting validation projects and technical equipment qualification
- Practical experience in a GMP-regulated environment
- Experience in creating risk analyses and formal test reports
- Experience in technical communication and stakeholder management with suppliers and internal operators
Languages
Additional
- Must be able to work on-site to organize and perform qualification activities; requires high flexibility and reliability for production-aligned scheduling.
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