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 within the pharmaceutical industry, focusing on the planning and execution of qualification activities for a global top-tier company. The specialist will independently organize and conduct validation efforts, creating and maintaining essential documentation such as risk analyses and validation master plans, and managing deviations and change requests. A key aspect of the role involves supporting the creation and maintenance of regulatory documents in both German and English. The position requires representing validation topics in cross-functional project teams, audits, and authority inspections, leveraging strong expertise in cleanrooms, temperature-controlled systems, and smoke studies. This is an excellent opportunity for a professional seeking a meaningful role in drug development with a highly reputable employer.
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
- Several years of professional experience in qualification (for Bachelor's degree holders) or initial professional experience (for Master's degree holders)
- Experience in the biopharmaceutical, pharmaceutical, or process engineering sector
- Knowledge in cleanrooms and smoke studies
- Expertise in biopharmaceutical production
- Foundational GMP knowledge and understanding of regulatory requirements
Languages
Additional
- Occasional flexible working hours and business travel required.
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