Senior Scientist, QC Excellence Instrumentation

vor 7 Monaten

Bern, Schweiz CSL Vollzeit

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In the role as 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 practice, 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 on 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

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.

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