Senior Scientist Digital Quality Control

Role: Senior Scientist Digital Quality Control, focusing on implementing and managing a global Laboratory Execution System (LES) to digitize QC laboratory workflows. Responsibilities: develop and verify digital method workflows in BIOVIA ONE Lab based on analytical SOPs, manage workflow lifecycle and data integrity, create User Requirements Specifications for instrument interfaces, and maintain global process documentation. Qualifications: University degree in Biology, Chemistry, Microbiology, or related field; 3-5 years in a GMP pharmaceutical testing environment with analytical instruments, and 2+ years in laboratory automation systems. Preferred: experience with BIOVIA ONE Lab or similar systems, knowledge of GMP regulations including 21 CFR Part 11, GAMP 5, EU Annex 11, and ALCOA+ principles. High-Value: focus on GMP-compliant digital lab automation, analytical instrument lifecycle management, data integrity, and global QC process standardization. Collaboration: cross-functional global teams across CSL Behring sites. Work Setup: not specified; salary range at hiring is $71,000–$90,000 plus benefits.