(Senior) Expert Hygiene & Disinfection (m/f/d)

Developing innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients., Everything we do here is about making people's lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.

Ihre Aufgaben

• 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), We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly. Proactive

  We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results. Reliable

  We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day. Excellent

  We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.

Ihr Profil

• 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

Wir bieten Ihnen

We offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7.

Local benefits

Our employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere.

Work-life balance

We want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more. Show all 6 services