Manager Sterility Assurance Validation (m/f/x)

For our location in Bern, we are looking for with immediate effect: Manager Sterility Assurance Validation (m/f/x) The Manager Sterility Assurance Validation is responsible for the APS concept of the Bern manufacturing site, which includes the creation, execution, evaluation, and reporting for the existing RABS and isolator filling lines. Tasks and core competencies: • Responsible for the further development and implementation of the APS concept for RABS and isolator filling lines with regard to regulatory requirements, best practice, and industry standards. • Conducting risk assessments in connection with interventions during aseptic filling as well as responsibility for employee training and qualification within the framework of APS. • SME for deviations and changes in the aseptic area. • Close cooperation with the global and local Sterility Assurance teams of the other locations to develop a holistic strategy for the control of microbial contamination and continuous improvement at the CSL Behring production site. • Creation, implementation, and maintenance of standards and processes for sterility assurance in accordance with global requirements, legal regulations, and industry standards (quality systems, guidelines, procedures, and work instructions). • Support for local and global capacity expansions as well as new projects to ensure a reliable supply for patients. • Cooperation with internal and external partners in the development of best-practice controls to ensure sterility for the strategy for the control of microbial contamination and lifecycle management - timely fulfillment of the required standards and regulatory requirements regarding validation activities affecting aseptic manufacturing (filling area including lyophilisators, sterilizers, isolator technology and auxiliary devices, employee training and qualification, cleaning and disinfection programs, media fill, etc.) • Support in the submission of regulatory documents as well as in internal and external GMP inspections (pre-approval and routine) as SME. Responsibility for answering inspection observations regarding APS. • Responsible for the creation of documentation (SOPs, risk assessments, etc. in the areas of sterility assurance validation, ensuring GMP compliance and adherence to the required standards. Ensuring a uniform appearance of all documentation across the entire global network. • Ensuring that global standards for best practice are maintained Qualifications and professional experience: • University degree in microbiology/biology/life sciences. • Proven sound technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment as well as personnel, including design and use as well as lifecycle management and compliance with cGMP. • +5 years of experience in the pharmaceutical manufacturing industry with direct experience in the sterility assurance of aseptic manufacturing and APS • Extensive professional experience in technical management regarding aseptic cleanrooms, aseptic behaviors, procedures, equipment, work clothing, consumables, as well as utility facilities • Proven experience in quality assurance and compliance with GxP, FDA, EU, and other regulatory guidelines • Experience in interaction with regulatory authorities, including submissions and inspections. • English and German language skills required in writing and speaking 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.