In your role as (Senior) Expert Hygiene & Disinfection (m/f/d) you will be responsible to define a Hygiene and Disinfection strategy and ensure implementation in the product portfolio through execution in the Value streams Machine and Disinfection. You are supporting in addition different innovative sterilization methods and their validation by working on interpretation and adoption to applicable standards.

Your tasks

Expert for all product groups concerning disinfectants, disinfection concepts and sterilization methodsPro-active surveillance of regulatory requirements for disinfection and biocides to foster the evaluation of production aids, raw materials as well as finished productsDevelopment of rationals to show the compliance of special sterilization methods like in line steam with the general sterilization standards on a global levelContact person to all units working on Hygiene and disinfection as well as sterilization methods and their validation, member in Cros functional teams in product developmentSupport the global harmonization of disinfection and cleaning agentsSet the strategic direction to In-Center Development groups in Value Streams, Registration/Regulatory Affairs and ProductCreate responses to authority requests to explain the sterilization concepts. Present during audits and document reviews the corresponding rationalsMid-term, a connection to the work in standard committees for sterilization and/or aseptic methods shall be established to understand and influence the generation of new standards in this fieldSupport a Design Control approach and provide expertise to Value Streams and Q&R for compliance with applicable regulations (EU directive, local countries regulations)

Your profile

Successfully completed master’s degree with scientific background in Microbiology, Chemistry and Hygiene; higher education, PhD preferredExperience of at least 5 years in Microbiology Laboratory or Sterilization Validation in pharmaceutical/medical fieldMinimum 2 years in working with DIN EN 556, DIN EN ISO 11135, DIN EN ISO 17665, DIN EN ISO 13408-1; EU Regulation 528/2012Advanced knowledge of sterilization standards like DIN EN 556, DIN EN ISO 11135, DIN EN ISO 17665, but also aseptic processing (DIN EN ISO 13408-1)Advanced knowledge of the EU Biocide regulation 528/2012Knowledge of further applicable standards (e. g. ISO13485 incl. MDSAP, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.) and regulations (e.g. MDR 2017/745)Knowledge of medical device risk management and related regulationsAbility to lead cross functional teams in a complex matrix organization without disciplinary authorityStrong team communication and problem-solving skills accompanied by analytical and entrepreneurial thinkingSees ahead to the future possibilities and translates them into breakthrough strategiesFluent in German and English, in written and spoken