Senior Validation Specialist (Pharmaceuticals) | CTA (m/w/d) BTA (m/w/d) Pharmakant (m/w/d)
agento PersonalManagement GmbH
Job Summary
This role is for a Senior Validation Specialist to join a leading pharmaceutical company in Biberach, Germany. The successful candidate will independently plan and execute qualification activities, focusing on room qualification, temperature-controlled systems, and smoke studies. Key responsibilities include creating and maintaining validation documents (risk analyses, VMPs), managing deviations and change requests, and supporting the creation of regulatory documents in both German and English. This position requires strong expertise in biopharmaceutical production, GMP knowledge, and excellent communication skills to represent technical topics in cross-functional project teams, audits, and inspections, contributing to the development of life-improving medications within a highly reputable organization.
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 extensive relevant professional experience, or comparable qualification.
Experience
- Several years of professional experience in qualification (for Bachelor's degree holders)
- Initial professional experience in qualification (for Master's degree holders)
- Extensive relevant professional experience (for vocational training holders)
- Experience in the biopharmaceutical, pharmaceutical, or process engineering sector
- Knowledge of cleanrooms and smoke studies
- Expertise in biopharmaceutical production
Languages
Additional
- Willingness for occasional shifted working hours and business trips.
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