Jobbeschreibung
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases. As a global health care company, we have a special goal: provide the best possible care. Join us to improve the quality of life for a growing number of patients around the world and be a vital part of our team.
#careerswithapurpose at Fresenius
Over 128,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
Fresenius Medical Care – Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products – that is Fresenius Medical Care.
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.
- 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 cross-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 of 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)
- 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