Hygiene Officer

Fresenius Medical Care is a global leader in kidney care. The St. Wendel site, with more than 1,800 employees, is one of the company's largest production sites in Germany and makes products for hemodialysis and peritoneal dialysis. They are looking for a hygiene officer (m/f/d) in the Care Enablement segment.

• Technical management and further development of hygiene management
• Responsibility for cleanroom qualification
• Contamination and hygiene risk management
• Defining and technically justifying hygiene requirements
• Governance and document management
• Standards and requirements management
• Training and qualification management
• On-site technical monitoring
• Disinfectant management
• Cleanroom clothing and laundry management
• Management of external service providers
• Hygiene monitoring and microbiological environment
• Continuous improvement and harmonization

• Completed degree in natural sciences, pharmacy, biotechnology, microbiology or a comparable technical field, preferably with a focus on microbiology, pharmacy, biotechnology, process engineering or a related field
• Alternatively, a comparable qualification with several years of relevant work experience in a GMP-regulated environment
• Several years of relevant work experience in the pharmaceutical or GMP-regulated industry, ideally in hygiene, microbiology, cleanroom technology/qualification, contamination control or quality assurance
• Solid experience in assessing and managing deviations, change controls, CAPAs and risk-based measures
• Experience in creating, assessing and maintaining SOPs, risk assessments, CCS, qualification documentation and other GMP-relevant requirements
• Experience in the technical management or coordination of internal interfaces and external service providers
• Experience with audits and inspections as well as preparing and supporting related activities
• Very good German skills, spoken and written.
• Good to very good English skills