Aseptic Process Scientist

For the Filling Line / Lyophilisation area within the Production department, we are looking for a

Aseptic Process Scientist

Are you looking for an exciting and varied challenge in the field of sterile filtration
and sterile filling and do you enjoy independent, precise and interconnected work in a
dynamic team? We have the ideal position for you.

You will work in the Filling, Lyophilisation area in production and be integrated into a multidisciplinary
team within the value stream.

Your main tasks include:

• Supporting the Aseptic Lead in implementing the new Annex 1 requirements, as well as integrating the Sterility Assurance Roadmap into routine processes
• Conducting and evaluating risk analyses, root cause analyses and risk assessments in the aseptic environment
• Creating and coordinating change requests affecting aseptic processes
• Creating and updating SOPs, work instructions and procedures related to aseptic processes, as well as ensuring the training status of employees in the aseptic area.
• Creating scripts for smoke studies and accompanying their execution
• Training and coaching employees regarding aseptic working methods and GMP-compliant execution
• Active participation in projects relevant to Sterility Assurance
• Supporting internal and external audits as well as regulatory inspections
• Initiating and coordinating improvement projects to further develop aseptic manufacturing processes
• Ensuring compliance with GMP requirements and sterility requirements

You bring the following qualifications and professional experience:

• Completed scientific studies (university or university of applied sciences) in pharmacy, chemistry, biology or comparable – alternatively long-standing experience in sterile pharmaceutical production
• Minimum 2 to 3 years of professional experience in the chemical, pharmaceutical or food industry and in a GMP environment
• Open, flexible personality with strong team orientation and motivation skills
• Solid knowledge in aseptic technology, GMP and regulations
• Experience dealing with regulatory requirements and audit processes
• Analytical thinking as well as independent, structured and reliable working style
• Strong communication skills and assertiveness
• Very good German and English skills, both spoken and written
• Good IT skills (MS Office, ideally also GMP-relevant systems such as TrackWise, LIMS, etc.)

Do you feel addressed? Then we look forward to receiving your online application and your complete application documents (compiled in one document).

What we offer

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About CSL Behring

CSL Behring is a globally leading company that develops and markets high-quality therapeutics for people with rare and serious diseases. With our medicines for the therapy areas of immunology, hematology, cardiovascular and metabolism, respiratory diseases and transplantation medicine, we keep our promise to improve the quality of life of patients in more than 100 countries. Learn more about CSL Behring .

CSL should be as diverse as the world we live in

As a global company with employees in over 35 countries, CSL stands for diversity, fairness and inclusion. Learn more about Diversity, Fairness & Inclusion at CSL.

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