\\nJob Description

CSL Behring is a leading global biotherapeutics company committed to its promise to save lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.

In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies. The CSL Behring Lengnau AG is part of CSL\\\'s ongoing global expansion strategy to support the company\\\'s long-term growth plans.

The new plant in Lengnau with its highly advanced facilities will manufacture innovative and promising therapeutics with the aim to enhance the quality of the patient\\\'s lives. One of the main products will be a recombinant coagulation factor to treat hemophilia B patients.

The Lengnau site project generates an investment of approximately a billion Swiss Francs and will create around 300 new jobs when it is operational.

Are you interested in being part of this exciting project?

To start in March 2020 or earlier, initially for 2 years, we are looking for an experienced

Senior Scientist Monitoring (m/f/d, 100%, fixed-term 2 years)

This position inside the Quality Management Validation department, is intended to ensure the development of the overall Monitoring program for all Clean Utilities (CU) and Environmental Monitoring (EM) for rooms in Lengnau in timely manner.

Your main Responsibilities and Accountabilities:

• You will support the qualification of clean utilities and rooms and you will be responsible of the deployment of the monitoring program covering trend evaluation and requalification as required
• Together with the Commissioning Verification and Qualification Team you will elaborate the definition of the qualification strategy and you will be responsible of the timely preparation/review of qualification documentation like Risk Assessment, Sampling Plan, Protocols/Reports
• You will work collaboratively with key stakeholders like Production, Commissioning Verification and Qualification, Engineering and Quality Control staff in order to ensure that all assigned activities are planned, coordinated and executed in an efficient time frame.
• You will support regulatory inspections by presenting qualification strategies and related monitoring documents.
• In addition, during the project phase the role is intended to support other activities managed by the validation team (e.g cleaning, process, sterilization), if needed and as appropriate in alignment with other tasks.

Your Profile:

• Several years of experience in Environmental Monitoring and Clean Utilities in Life Sciences / Pharma / Biotech companies
• Proven experience in a cGMP & GxP environment
• Deep knowledge of cGMP including current knowledge of industry guidance documents and standards focusing on environmental monitoring and monitoring of clean utilities
• Degree in Life Sciences (Physics, Chemistry, Biology, Microbiology, etc.) or Engineering (focus on clean utilities and cleanroom)
• Fluent English required, some proficiency in German (written and spoken) beneficial

If you join us, you will:

• Work with the state of the art technology and processes in the field, the whole environment being very modern
• Be part of a motivated, multicultural team
• Work together in a challenging environment and develop you knowledge
• Contribute to and benefit from our startup spirit within a worldwide pharmaceutical company

The position is initially limited to 2 years. An extention is possible.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.

About Us

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world\\\'s largest collectors of human plasma, which is used to create CSL\\\'s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!\\n \\n \\n \\n \\n \\n

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