Validation Expert | Validation Expert m/w/d 5622€ plus Prämien
apero GmbH Arbeitnehmerüberlassung
Job Summary
As a Validation Expert, you will be responsible for coordinating, planning, and executing the validation of aseptic processes (Media Fills), microbiological shelf lives, and personnel qualifications. Your day-to-day will involve creating, maintaining, and aligning master validation plans, protocols, reports, and risk analyses, as well as managing deviations and change requests. You will evaluate and summarize study results, support the creation of regulatory documents, and represent complex technical topics in project teams, audits, and inspections. This role requires close collaboration with internal and external partners, ensuring compliance with internal, global, and regulatory guidelines, and contributing your expertise to a global company environment.
Required Skills
Education
Master's degree in a natural science or technical field, or a Bachelor's degree with extensive professional experience in a relevant field
Experience
- Several years of experience in process validation, preferably aseptic processes
- Several years of professional experience in the biopharmaceutical, pharmaceutical, or process engineering sector
Languages
Additional
- Availability for on-call duty, including short notice, requiring good accessibility to the work location.
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