Senior Validation Specialist | Senior Validation Specialist (m/w/d)
siecon personalmanagement GmbH
Job Summary
As a Senior Validation Specialist, you will independently plan and execute qualification activities, collaborating closely with production departments and support units. Your daily tasks will include creating, maintaining, and aligning initial, change, and routine qualifications, along with higher-level documents like risk analyses and Validation Master Plans (VMPs). You will also be responsible for processing deviations and change requests, and supporting the creation of regulatory documents in both German and English. Leveraging your expertise and strong English skills, you will represent your field in cross-functional project teams, internal and external meetings, and during audits and regulatory inspections. This role offers the opportunity to build and expand specialized knowledge in areas like room qualification, temperature-controlled systems, and smoke studies, contributing to a global pharmaceutical environment.
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 qualification within the biopharmaceutical, pharmaceutical, or process engineering sector
- Experience with cleanrooms and smoke studies
- Knowledge of biopharmaceutical production
- Profound GMP knowledge and understanding of regulatory requirements
Languages
Additional
- Willingness for occasional shifted working hours and business trips.
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