Senior Scientist, QC Excellence Instrumentation, Bern
vor 1 Tag
CSL
Location:Bern, Switzerland
Job Category:Other
Job Reference:7794c55d79a2
Job Views:10
Posted:21.01.2025
Expiry Date:07.03.2025
Job Description:CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In the role of Senior Scientist, QC Excellence Instrumentation, you will support laboratory instrumentation and automation infrastructure in the operational QC testing environment. You will carry out equipment qualifications for our site in Bern, Switzerland and collaborate with our sites in Europe, Australia, and the United States for global qualification projects.
Your responsibilities include, but are not limited to:
- Support laboratory instrumentation and automation infrastructure in an operational testing environment.
- Ensure laboratory instrumentation and equipment are qualified, calibrated, and maintained according to company policies and procedures and in compliance with GxP requirements.
- Create documentation in English and German for qualification, validation, and lifecycle management of existing and newly implemented laboratory automation systems, analytical instruments, and software applications in collaboration with Engineering and I&T departments.
- Manage local and global qualification and validation projects.
- Collaborate with internal and external stakeholders within qualification and validation projects for technical requirement specifications, data integrity, and automation activities.
- Support update of procedures related to laboratory instrumentation and computerized systems (i.e. USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practices, as well as harmonization within the global organization.
- First level user support for operational QC labs on instrumentation providing technical support, coordinating repairs, and support through QC external providers (i.e. Laboratory Execution Systems, I&T, external service providers).
Who you are:
In this role, you will collaborate with relevant stakeholders to ensure laboratory equipment and automation systems are operating in a qualified environment. With your proactive and self-responsible approach, you take decisions and drive progress forward.
The below competencies will help you to be successful in this role:
- University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.).
- 5+ years' experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, experience in equipment qualification or CSV and lifecycle activities.
- First project management experience in an operational environment.
- Knowledge of regulations on computerized systems and laboratory automation and willingness to extend skills and know-how in the field.
- Strong written & verbal communication in German and English, both oral and written, to ensure effective collaboration with cross-functional teams both locally and globally across all CSL Behring sites.
- Strong analytical/problem-solving, technical IT affinity, and organizational skills.
- Able to work independently and as a team member in a high-performance environment.
We encourage you to make your well-being a priority. It’s important and so are you.
Please note that if you are NOT a passport holder of the country for the vacancy, you might need a work permit. Check our Blog for more information.
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