Senior Scientist, QC Excellence Instrumentation Specialist
Vor 5 Tagen
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In this role, you will support laboratory instrumentation and automation infrastructure in the operational QC testing environment.
Key Responsibilities- 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 the 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.
- Provide 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).
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 will take decisions and drive progress forward.
Requirements- 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 and 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.
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Bern, Bern, Schweiz CSL Behring VollzeitAbout the RoleWe are seeking a highly skilled Senior Scientist to join our team at CSL Behring. As a Senior Scientist, QC Excellence Instrumentation, you will play a key role in supporting laboratory instrumentation and automation infrastructure in our operational QC testing environment.Key Responsibilities:Support laboratory instrumentation and automation...
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Bern, Bern, Schweiz CSL Behring VollzeitAbout the RoleWe are seeking a highly skilled Senior Scientist to join our team at CSL Behring. As a Senior Scientist, QC Excellence Instrumentation, you will play a critical role in supporting laboratory instrumentation and automation infrastructure in our operational QC testing environment.Key Responsibilities:Support laboratory instrumentation and...
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