Senior Validation Specialist (Pharmaceuticals) | CTA (m/w/d) BTA (m/w/d) Pharmakant (m/w/d)

agento PersonalManagement GmbH

Biberach an der Riß, Baden-Württemberg, Deutschland
Published Jun 24, 2025
Full-time
Permanent

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

German (Fluent)English (Fluent)

Additional

  • Occasional flexible working hours and business travel required.