Get started now as a pharmacist with Randstad professional solutions! Our friendly colleagues in Biberach also have the right position for you. We are currently looking for a Validation Expert on behalf of our business partner in the pharmaceutical industry. Apply today and start your new job tomorrow! We actively embrace diversity, which is why we welcome all applications.
Here's what we offer
1. Attractive salary package with Christmas and vacation bonuses
2. Reimbursement of travel expenses
3. Up to 30 days vacation per year
4. Development of skills
5. Open corporate culture
Your tasks
6. Assume independent responsibility for the support of products in the context of process and cleaning validation, including representation in interdisciplinary project team, compliance and customer meetings (internal or external)
7. Coordination of validation activities
8. Independent planning of process and cleaning validations, incl. creation, maintenance or revision of validation documents (validation master plans, validation reports, sampling plans, risk analyses) in coordination with relevant interfaces, such as production and analytical areas for process and cleaning validation, primarily in English, incl. cooperation in the event of associated deviations
9. Independent research and GMP-compliant evaluation of analytical and operational results and data, e.g. from electronic systems
10. Collaboration on control strategy, risk analysis and other documents in cooperation with the development unit, production, analytical units or other relevant interfaces
11. Evaluation of changes in manufacturing/cleaning processes of products with regard to process and cleaning validation relevance
12. Evaluation of deviations with regard to process and cleaning validation relevance
13. Creation, maintenance and revision of submission documents, incl. answering inquiries from authorities regarding process and cleaning validation
14. Representation of validation topics in audits and inspections
15. Taking on the role of change manager with regard to change management if required
Your profile
16. Completed Master's degree in the natural sciences/technical field with several years of professional experience, alternatively Bachelor's degree or completed scientific training with many years of professional experience in the GMP environment (pharmaceuticals, biotechnology) or in the field of process and cleaning validation, preferably in the production of active ingredients
17. Several years of experience in the biopharmaceutical/pharmaceutical/process engineering field
18. Comprehensive GMP knowledge and knowledge of regulatory requirements
19. Very good PC skills in the common MS Office applications
20. Experience with SAP and/or TrackWise an advantage
21. Fluent German and very good written and spoken English skills
22. Very high degree of initiative, flexibility and sense of responsibility
23. An independent, structured way of working and a high level of commitment
24. Assertiveness, communication and teamwork skills, organizational skills and social competence
25. High quality awareness and willingness to acquire an understanding of process technology