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Open nowPosted yesterday

Senior Scientist Digital Quality Control

job-room.ch88,451 open roles

Where
Berne, BE, Switzerland
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Your applicationOpen nowSenior Scientist Digital Quality Controljob-room.ch · Berne, BE, Switzerland

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  5. 33.9%30 days
This job: posted yesterday

job-room.ch median: 4 days open

The posting

Innovative and committed to patients worldwide.

CSL Behring is a global biotechnology leader driven by its promise to save lives. At our manufacturing site in Bern, Switzerland, we develop and manufacture life-saving therapies for people living with serious and rare diseases around the world.

We are currently looking for a Senior Scientist Digital Quality Control (100%) - (m/f/d) to join our Global Quality Control organization.

In this role, you will play a key part in driving the digital transformation of our QC laboratories by implementing and continuously improving our global Laboratory Execution System (LES). Working closely with QC laboratories, Global Engineering and IT across multiple manufacturing sites, you will help shape the future of digital laboratory operations and contribute to the standardization of Quality Control processes worldwide.

Responsibilities

  • Design, configure and maintain digital laboratory method workflows within the BIOVIA ONE Lab Laboratory Execution System (LES) based on analytical method SOPs and ISA-88 principles.
  • Create, execute and document test cases to verify digital workflows and support their successful deployment across QC laboratories.
  • Manage the lifecycle of digital method workflows, including relevant master and dynamic data, system administration and continuous improvement activities.
  • Partner with QC laboratories, Global Engineering, IT and other cross-functional stakeholders to implement and standardize digital laboratory processes across CSL Behring manufacturing sites.
  • Troubleshoot system and workflow-related issues and provide technical support to ensure reliable day-to-day laboratory operations.
  • Develop User Requirement Specifications (URS), support laboratory instrument and automation interfaces, and maintain relevant global process documentation in accordance with GMP and data integrity requirements.
  • Identify opportunities for process improvement, standardization and automation, contributing to the continued development of Global QC digital capabilities.

Qualifications

  • Bachelor's or Master's degree in Biology, Chemistry, Microbiology, Biotechnology or another relevant scientific discipline.
  • 3-5 years of experience in a pharmaceutical Quality Control or R&D laboratory within a GMP-regulated environment, combined with at least 2 years of experience in laboratory automation, digital laboratory solutions or process automation.
  • Strong understanding of analytical laboratory processes and workflows; experience with Laboratory Execution Systems (LES), LIMS or BIOVIA ONE Lab is a strong advantage.
  • Good understanding of GMP computerized systems, data integrity principles and computerized system validation is desirable.
  • Strong analytical and troubleshooting capabilities with a high affinity for digital technologies and process improvement.
  • Excellent communication skills in English and good spoken German, enabling effective collaboration with local and international stakeholders.
  • Ability to work independently while collaborating effectively across international, cross-functional teams in a dynamic project environment.

About this position

As part of our Global Digital QC team, you will primarily support the QC laboratories in Bern while collaborating closely with colleagues across Australia, Germany, Switzerland and the United States.

This international role offers the opportunity to develop deep expertise in one of CSL Behring's key digital laboratory platforms and actively shape the future of Quality Control digitalization across our manufacturing network.

You will work at the intersection of laboratory science, digital technology and global Quality Control, helping translate analytical laboratory processes into standardized and reliable digital workflows while contributing to the continued evolution of our global QC capabilities.

Interested in this opportunity? We look forward to receiving your application. Please submit your CV, employment references and degree certificates together as one file.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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