Hygiene Monitoring Staff (m/f/d)

Conducting particle measurements in clean rooms as well as cleansing media (pressure air and nitrogen) First assessment and evaluation of the results of particle monitoring microbiological hygiene monitoring in aseptic production and solid production (active air germ measurements, surface investigations and sampling of ultrapure media systems) Implementation of microbiological hygiene monitoring on systems in the context of cleaning validation Performance of equipment qualifications and requalifications, e.g. for particle meters, incubators and refrigerators Responsibility for laboratory and monitoring equipment, including incubators, refrigerators and particle meters, including implementation and monitoring of the required monitoring Maintenance and maintenance of the sampling cooler for the test of pure steam Creation of GMP-relevant documents, e.g. forms for raw data documentation as well as application-specific work instructions Storage and processing of samples from microbiological hygiene monitoring of clean rooms and hygiene zones in the Growth Direct System (automated incubation and evaluation) Production of APS Qualification Test Sets for Production Employees under Aseptic Conditions in the Laboratory

Complete technical or scientific vocational training or alternatively multiannual professional experience in a GMP-regulated environment, in particular in hygiene areas Relevant professional experience (approximately 2 to 5 years) in the pharmaceutical, biotechnological or comparable regulated industry Knowledge of ISO 14644 (purity classification and clean room monitoring) desirable Knowledge of EU-GMP Annex 1 (production of sterile medicinal products) desirable High flexibility in working hours Excellent quality awareness and careful working High level of self-responsibility and self-organisation Good general IT skills in dealing with common software applications, SAP skills Reliability, fast conception, independent and structured operation, as well as strong team skills Very good knowledge of German in word and writing Basic knowledge of English language of advantage

Attractive Benefits Work-life balance Personal growth and development Health and well-being