Validation Expert, Pharmaceutical Engineering | Biotechnologe (m/w/d) Pharmaingenieur (m/w/d)
agento PersonalManagement GmbH
Job Summary
This role seeks a dedicated Validation Expert to join a leading global pharmaceutical company in Biberach. The primary focus is coordinating, planning, and executing the validation of critical aseptic processes, including Media Fills, microbiological shelf life studies, and personnel qualifications. Day-to-day responsibilities involve creating, maintaining, and aligning Master Validation Plans, protocols, reports, risk analyses, and managing associated deviations and change requests. You will evaluate study results, support the creation of regulatory submission documents, and act as a key representative for complex technical topics in cross-functional project teams, audits, and authority inspections. Success requires comprehensive GMP and regulatory knowledge, strong communication skills, particularly in English, and a structured, independent working style. This position offers immediate entry into a top-tier company with excellent long-term security and a high probability of permanent employment.
Required Skills
Education
Master's degree in Natural Science or Technical field; alternatively, Bachelor's degree with extensive professional experience
Experience
- Multiple years in process validation, preferably aseptic processes
- Multiple years of professional experience in the biopharmaceutical, pharmaceutical, or process engineering sector
Languages
Additional
- Must be available for on-call duty (Bereitschaftsdienst), including short-notice availability. Good accessibility to the Biberach location is required.
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