Manager Sterility Assurance Monitoring (m/f/x)

For the local Sterility Assurance Organization at the Bern site, we are looking for an experienced specialist in the field of sterility assurance with a focus on environmental monitoring and microbiological control of aseptic processes in a leading function for the area of environmental monitoring. You will report to the Managers (m/f/x) of the Sterility Assurance Organization Bern and will be in close exchange with the experts from sterility assurance, quality assurance, and production: Manager Sterility Assurance Monitoring (m/f/x) Competencies and responsibilities: • Responsible for the technical management and the concepts of environmental monitoring, taking into account applicable international regulations, ISO standards, and industry standards • Maintenance and continuous further development of the GMP monitoring system for cleanrooms, personnel, disinfectants, and equipment, taking into account global specifications and the contamination control strategy • Transfer of global monitoring standards to local monitoring systems • Responsible for the creation and updating of department-specific SOPs and specifications for environmental monitoring. • Writing of process risk analyses and appearing as an SME in the field of sterility assurance regarding contamination risks • Evaluation of change requests and deviations as an expert for environmental monitoring in relation to hygiene status, impact on the manufacturing process, and monitoring systems. • Review of online data for the physical and microbiological monitoring of areas C & D; initiation of deviations if necessary and provision of data for root cause analyses. • Preparation of documents for regulatory submissions regarding environmental monitoring as well as processing of regulatory inquiries. • Subject matter expert for environmental monitoring during inspections and support in clarifying inspection findings. • Participation in global working groups and projects in the context of environmental monitoring. • Responsibility for the creation of trend reports and communication of results in technical committees and quality management reviews. • Development of risk analyses, test plans, and reports for the performance qualification of cleanrooms in environmental monitoring. • Implementation of improvements in aseptic processes, coordination of the necessary measures, and monitoring of progress Qualification and professional experience: • University degree in microbiology/ biology/ life sciences/ pharmacy or comparable qualification. • Professional experience in the pharmaceutical manufacturing industry • Experience in quality assurance and compliance with GxP, FDA, EU, and other regulatory guidelines, as well as ISO standards • Knowledge and experience in sterility assurance for aseptic manufacturing: aseptic cleanrooms, aseptic behaviors, and contamination control with a direct relation to environmental monitoring • German and English language skills required in written and spoken form • Communication and teamwork skills • Balanced understanding of regulatory cGMP and operational requirements • Understanding of production-related contexts and the ability to explain these in an understandable form, both written and oral • Cross-departmental, structured, and solution-oriented thinking and acting CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.