Senior Scientist Digital Quality Control

CSLKankakee, IL
Hybrid

About The Position

CSL Behring is currently looking for a Senior Scientist Digital Quality Control (100%) – (m/f/d) to join their Global Quality Control organization. This role is crucial in driving the digital transformation of QC laboratories by implementing and improving the global Laboratory Execution System (LES). The position involves close collaboration with QC labs, Global Engineering, and IT across multiple manufacturing sites to shape digital laboratory operations and standardize QC processes globally. This role offers the opportunity to become an expert in a key digital laboratory platform and actively contribute to the future of Quality Control digitalization.

Requirements

  • 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.
  • 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.

Nice To Haves

  • 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.

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.

Benefits

  • For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
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