We are currently seeking a qualified Qualification Engineer for a business partner in Singen. Are a secure and fair income and good social benefits just as important to you as a responsible position and long-term prospects with a renowned pharmaceutical company ? Then join us – your satisfaction is our goal! Apply online now! We value equal opportunities and welcome applications from people with disabilities, whose inclusion is of particular importance to us.
Here's what we offer
1. Performance-based salary package depending on qualifications and professional experience
2. Attractive social benefits, e.g. holiday and Christmas bonuses
3. Company pension scheme contribution after the end of the probationary period
4. Tailored professional development opportunities and free language courses
5. Special conditions when buying concert tickets, electronic devices, sporting goods and much more.
6. Possibility of predominantly remote work by arrangement
Your tasks
7. Creation and implementation of spatial qualifications (DQ, IQ, OQ)
8. Evaluation of measurement data within the framework of cleanroom qualifications or requalifications and monitoring measures
9. Creation of trend reports on particle monitoring
10. Creation and processing of deviations, CAPAs and CCAs
11. Transfer of existing qualifications into the document management system
12. Systematic review of all existing room qualifications, e.g. cleanrooms, production rooms and storage areas
13. Review of existing qualification documentation
14. Identification of documentation gaps and deviations from current regulatory requirements
15. Conducting structured gap assessments
Your profile
16. Completed studies in the field of pharmaceutical technology, process engineering, qualification or a related field
17. Ideally, experience in equipment, media or cleanroom qualification in a GMP-regulated environment.
18. Knowledge of Data Integrity (21 CFR Part 11) is desirable.
19. Proficient use of common MS Office applications
20. CAD skills are desirable.
21. Good German and English skills, both spoken and written.
22. Self-initiative as well as communication and teamwork skills
23. Commitment and a high degree of flexibility