Aseptic Process Scientist

CSL Behring is a worldwide leading biotech company committed to its promise to save lives. In Bern, we develop and distribute life-saving therapies for people with severe and rare diseases worldwide with over 1'800 employees. For our location in Bern, we are looking for a motivated and dedicated person as: Aseptic Process Scientist As an Aseptic Process Scientist, you will support the Aseptic Leads in the implementation of regulatory requirements, the further development of our Sterility-Assurance-Strategy, and the sustainable anchoring of aseptic processes in everyday production. You will work closely with internal stakeholders and international sites, making an important contribution to ensuring the highest quality standards. Your tasks include: • Supporting the Aseptic Lead in the implementation of the new Annex 1 requirements and the integration of the Sterility Assurance Roadmap into routine processes. • Carrying out and evaluating risk analyses, cause analyses, and risk assessments in the aseptic environment. • Creating and coordinating change requests that affect aseptic processes. • Creating and updating SOPs, work instructions, and procedures that affect aseptic processes, as well as ensuring the training status of employees in the aseptic area. • Creating scripts for smoke studies and accompanying their implementation. • Training and coaching employees on aseptic working methods and GMP-compliant implementation. • Active participation in projects relevant to Sterility Assurance. • Supporting internal and external audits as well as authority inspections. • Initiating and coordinating improvement projects for the further development of aseptic manufacturing processes. • Ensuring compliance with GMP requirements and sterility requirements. Qualifications & experience: • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a comparable natural science discipline - alternatively, long-standing experience in sterile pharmaceutical production. • Open, flexible personality with pronounced team orientation and motivation ability. • In-depth knowledge of aseptic technology, GMP, and regulatory requirements. • Experience in dealing with regulatory requirements and audit processes. • Analytical thinking as well as independent, structured, and reliable working methods. • Pronounced communication strength and assertiveness. • Very good German and English language skills in word and writing are mandatory. • Good IT skills (MS Office, ideally also GMP-relevant systems such as TrackWise, LIMS, etc.). About this position You will report to the Aseptic Process Excellence Lead and work in a dedicated team of Aseptic Leads and Aseptic Process Scientists within the Value Stream Filling and Lyophilisation in production. In this function, there is close cooperation with the Aseptic Lead as well as numerous cross-functional interfaces, particularly with Quality Assurance and Sterility. Are you interested? Then we look forward to your online application. Your application should include a resume/CV as well as work certificates and copies of diplomas in the original language and/or relevant transcripts. Please combine your files, including CV, into one document. 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.