Job Information
Fresenius Medical Care North America (Senior) Expert Hygiene & Disinfection (m/f/d) in Bad Homburg, Germany
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 methods
Pro-active surveillance of regulatory requirements for disinfection and biocides to foster the evaluation of production aids, raw materials as well as finished products
Development of rationals to show the compliance of special sterilization methods like in line steam with the general sterilization standards on a global level
Contact person to all units working on Hygiene and disinfection as well as sterilization methods and their validation, member in Cros functional teams in product development
Support the global harmonization of disinfection and cleaning agents
Set the strategic direction to In-Center Development groups in Value Streams, Registration/Regulatory Affairs and Product
Create responses to authority requests to explain the sterilization concepts. Present during audits and document reviews the corresponding rationals
Mid-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 field
Support 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 preferred
Experience of at least 5 years in Microbiology Laboratory or Sterilization Validation in pharmaceutical/medical field
Minimum 2 years in working with DIN EN 556, DIN EN ISO 11135, DIN EN ISO 17665, DIN EN ISO 13408-1; EU Regulation 528/2012
Advanced 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 528/2012
Knowledge 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 regulations
Ability to lead cross functional teams in a complex matrix organization without disciplinary authority
Strong team communication and problem-solving skills accompanied by analytical and entrepreneurial thinking
Sees ahead to the future possibilities and translates them into breakthrough strategies
Fluent in German and English, in written and spoken