Senior Validation Specialist | Senior Validation Specialist | M/W/D - Referenz 000965
consult16 GmbH
Job Summary
As a Senior Validation Specialist, you will independently plan and execute qualification activities, collaborating closely with production and support teams. Your responsibilities include creating, maintaining, and aligning initial, change, and routine qualifications, as well as higher-level documents like risk analyses and Validation Master Plans (VMPs). You'll also manage deviations and change requests, and support the creation of regulatory documents in both German and English. Leveraging your expertise and strong English skills, you will represent technical topics in cross-functional project teams, internal/external meetings, audits, and regulatory inspections. This role involves developing specialized knowledge, adapting to new requirements, and coordinating validation topics such as room qualification, temperature-controlled systems, and smoke studies within a global corporate environment. The position is initially limited until December 31, 2026, and is based in Upper Swabia, Germany, within an internationally successful pharmaceutical company.
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
- Knowledge in cleanrooms and smoke studies
- Expertise in biopharmaceutical production
- In-depth GMP knowledge and understanding of regulatory requirements
Languages
Additional
- Occasional flexible working hours and business travel required. Initial contract duration until December 31, 2026. Work location in Upper Swabia, Germany.
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