GMP Qualification and Validation Specialist (Biologist/Technician) | Biologe (m/w/d)

Job Summary

This role seeks a highly organized GMP Qualification and Validation Specialist, ideally a Biologist or Technician, to join a team in Idar-Oberstein on a two-year contract. The core responsibilities involve the planning, execution, and detailed documentation of requalification activities for cleanroom facilities and process equipment, including crucial computer system validation (CSV). The specialist will be instrumental in ensuring all facilities meet current GMP standards, developing and revising Standard Operating Procedures (SOPs), and collaborating across teams to implement technical optimizations. Success in this position requires a background in natural sciences, biotechnology, or process engineering, coupled with multi-year practical experience in qualification under GMP (URS, RA, DQ). Candidates must possess strong technical acumen, familiarity with ERP systems like SAP, and excellent analytical problem-solving skills to manage deviations, changes, and CAPA measures effectively.