We are currently looking for a Senior Validation Specialist (m/f/d) on behalf of our business partner from the pharmaceutical industry in Biberach .
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. As a rule, a permanent 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 Senior Validation Specialist, you will organize the planning and implementation of qualification activities independently, efficiently and in a target-oriented manner in coordination with the specialist areas of production and the supporting units.
11. You will create, maintain and coordinate initial, change and routine qualifications as well as higher-level documents such as risk analyses and VMPs and responsibly process deviations and change requests. You will also support the creation and maintenance of approval documents. The documents are created in German and English.
12. With your expertise and very good English language skills, you will represent the specialist topics in interdisciplinary project teams/meetings with internal and external partners as well as during audits and inspections by authorities.
13. You will build up and expand specialist expertise for the specialist and key topics. You will recognize, check, adapt and apply new requirements, also taking into account global aspects, in consultation with the manager.
14. You will plan and coordinate the specialist topics of room qualification, qualification of temperature-controlled systems such as cold storage and freezer rooms and smoke studies that you are responsible for within the team and also work on the topics in the global environment of the company association.
Your profile
15. Completed scientific or technical studies (Bachelor with several years or Master with first professional experience) in the field of qualification
16. or completed technical/scientific vocational training with many years of relevant professional experience or comparable qualification
17. Experience in the biopharmaceutical/pharmaceutical/process engineering field
18. Knowledge of cleanrooms and smoke studies, as well as expertise in biopharmaceutical production
19. Sound GMP knowledge and knowledge of regulatory requirements
20. Personally, you are characterized by your strong communication skills, your planning and organizational skills as well as your independent and responsible way of working, which is characterized by a high level of initiative, systematic approach and team spirit
21. Outstanding interpersonal and intercultural skills, combined with excellent communication and presentation skills in English and German
22. Willingness to work occasional staggered hours and travel on business