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 based on analytical method SOPs and ISA-88 process principles.
- Create, execute and document test cases to verify digital method workflows and ensure successful deployment.
- Manage the lifecycle of digital method workflows, including master data, dynamic data and system administration activities.
- Support the implementation and continuous improvement of the global Laboratory Execution System across CSL Behring manufacturing sites.
- Collaborate closely with QC laboratories, Global Engineering, IT and cross-functional stakeholders to standardize laboratory processes and digital solutions.
- Troubleshoot system-related issues and support end users to ensure reliable day-to-day laboratory operations.
- Develop User Requirement Specifications (URS) and contribute to interface concepts for laboratory instruments and automation solutions.
- Maintain global process documentation and support data integrity initiatives in accordance with GMP computerized system requirements.
- Contribute to the continuous development of CSL Behring's global QC digitalization strategy through process improvements and automation initiatives.
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 operating within a GMP-regulated environment.
- At least 2 years of experience working with laboratory automation systems, digital laboratory solutions or process automation.
- Strong understanding of analytical laboratory processes and laboratory workflows.
- Experience with Laboratory Execution Systems (LES), LIMS or BIOVIA ONE Lab is considered a strong advantage.
- Good understanding of GMP computerized systems, data integrity principles and computerized system validation is desirable.
- Excellent communication skills in English and good spoken German, enabling close collaboration with local QC laboratories.
- Strong analytical thinking, troubleshooting skills and a high affinity for digital technologies.
- Ability to collaborate effectively within international cross-functional teams while working independently in a dynamic project environment.
About this position
- Reporting to the 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 role offers the opportunity to become an expert in one of CSL Behring's key digital laboratory platforms and actively shape the future of Quality Control digitalization.
Interested in this opportunity? We look forward to receiving your application, including your CV, employment references, and degree certificates.
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.
