Senior Scientist Digital Quality Control

CSL; Bern; On-site; CHF 120,000 - 150,000; Full time

Job summary

CSL Behring in Bern is seeking a Senior Scientist Digital Quality Control to drive the digital transformation of QC laboratories. The role focuses on implementing and enhancing the global Laboratory Execution System (LES) across sites, working with Global QC, Engineering and IT to standardize processes worldwide.

You will translate analytical workflows into robust digital pipelines, ensure GMP data integrity, and contribute to the evolution of CSL Behring’s digital QC capabilities across the

Qualifications

• Bachelor’s or Master’s degree in Biology, Chemistry, Microbiology, Biotechnology or similar.
• 3–5 years in pharma QC or R&D in GMP environments; plus 2+ years in automation/digital lab solutions.
• Experience with LES, LIMS or BIOVIA ONE Lab is advantageous.

Responsibilities

• Design, configure and maintain digital lab workflows within BIOVIA ONE Lab LES.
• Create, execute and document test cases for digital workflows.
• Manage lifecycle of digital method workflows and data, with GMP compliance.
• Collaborate with QC labs, Global Eng, IT to standardize digital processes.
• Troubleshoot issues and provide technical support for daily QC operations.
• Develop URS and maintain process docs for data integrity and validation.
• Identify opportunities for automation and global QC digital capability growth.

Skills

GMP knowledge

Lab automation

Digital lab solutions

BIOVIA ONE Lab

Analytical methods

English

German

Education

Bachelor or Master in life sciences

Tools

BIOVIA ONE Lab

LIMS

LES

Job description

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.