For a renowned pharmaceutical company based in Biberach, we are currently looking for a committed personality as Validation Expert (m/f/d).
Here's what we offer
1. Attractive salary and long-term job security through group affiliation
2. Up to 30 days vacation per year
3. Contribution to company pension scheme after end of probationary period
4. Extensive social benefits, including Christmas and vacation bonuses
5. Reimbursement of travel expenses
6. Generally an open-ended employment contract
7. Good chances of being taken on by our business partners
8. Tailored further training opportunities and free language courses
9. A wide range of employee benefits
Your tasks
10. As a Validation Expert, you will coordinate, plan and process the validation of aseptic processes (media fills), microbiological service lives and personnel qualifications.
11. You will create, maintain and coordinate master validation plans, validation protocols/reports, risk analyses, regulations and any associated deviations, change requests and measures as required.
12. In your new role, you will evaluate and summarize the corresponding results of the previously planned studies. This will include assisting in the preparation of regulatory documents and answering regulatory questions.
13. With your expertise and good English language skills, you will represent the complex technical topics in interdisciplinary project teams/meetings with internal and external partners as well as during audits and inspections by authorities.
14. You will also be responsible for coordinating content with customers and interfaces, taking into account internal and global regulations as well as legal and official requirements. This also includes planning, coordinating and evaluating further studies (internal/external) and assessments in close cooperation with the manager.
15. You will plan and coordinate the specialist topics you are responsible for within the team and also work on the topics in the global environment of the company association.
Your profile
16. Completed Master's degree in the natural sciences or technical field with several years of experience in the field of process validation, preferably aseptic processes, alternatively completed Bachelor's degree with corresponding many years of professional experience
17. Several years of professional experience in the biopharmaceutical, pharmaceutical or process engineering sector
18. Comprehensive GMP knowledge and knowledge of regulatory requirements
19. Very good PC skills in the common MS Office applications
20. Fluency in written and spoken English
21. Careful, efficient, independent and structured way of working as well as assertiveness and ability to work in a team due to numerous interfaces
22. Good accessibility to the place of work is required for participation in the on-call service, even at short notice