Senior Validation Specialist | Biologe (m/w/d)
expertum Holding GmbH
Job Summary
As a Senior Validation Specialist, you will independently conduct qualifications and validations of pharmaceutical production facilities, ensuring compliance with current GMP guidelines. Leveraging your experience in biopharmaceutical production, you will coordinate all involved departments and support a dedicated team through all phases of qualification and validation. Key responsibilities include creating, maintaining, and aligning initial, change, and routine qualifications, as well as overarching documents like risk analyses and Validation Master Plans (VMPs). You will also assist in preparing and maintaining regulatory documents in both German and English, and adapt to new global requirements. This role offers the opportunity to work on specialized topics such as room qualification, temperature-controlled facilities, and smoke studies within a global company network, requiring strong communication and organizational skills.
Required Skills
Education
Completed scientific or technical degree (Bachelor with several years of experience or Master with initial professional experience) in Qualification, or completed technical/scientific vocational training with many years of relevant professional experience, or comparable qualification.
Experience
- Professional experience in biopharmaceutical, pharmaceutical, or process engineering fields
- Experience in cleanrooms and smoke studies
- In-depth GMP knowledge and understanding of regulatory requirements
- Experience in coordinating involved departments and supporting teams during qualification and validation processes
Languages
Additional
- Willingness to occasionally work shifted hours and undertake business trips.
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