Senior Scientist Digital Quality Control

Responsibilities

• Create digital method workflows in the BIOVIA ONE Lab Laboratory Execution System based on analytical method SOPs and process maps structured according to ISA-88 principles.
• Create and execute test cases to verify digital method workflows.
• Manage the lifecycle of digital method workflows, including master and dynamic data management, as a Business Administrator for BIOVIA ONE Lab.
• Develop User Requirements Specifications (URS) for laboratory instrument interfaces.
• Maintain global process documents related to the QC Laboratory Execution System.
• Support QC business process standardization and global data integrity initiatives related to laboratory automation and analytical instrumentation.

Qualifications

• Education: University degree in a relevant scientific discipline (e.g., Biology, Chemistry, Microbiology, or a related field).
• Experience: 3-5 years of experience in a pharmaceutical GMP testing environment, including the use of a variety of analytical instruments, instrument lifecycle management activities, and data integrity practices.
• At least 2 years of experience working with laboratory automation systems in a QC or R&D environment.
• Experience with BIOVIA ONE Lab or a comparable Laboratory Execution System is considered an advantage.
• Knowledge of GMP computerized system regulations and industry guidance, including GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles, is desirable.

About the Role

Collaborate with QC teams worldwide to implement a global Laboratory Execution System (LES), enabling the transition from paper-based laboratory documentation to digital method workflows.

Skills

• Strong written and verbal communication skills in English, with the ability to collaborate effectively with cross-functional teams across global CSL Behring sites.
• Strong analytical and problem-solving skills, a high affinity for digital technologies and IT systems, and excellent organizational abilities.
• Ability to work both independently and collaboratively in a fast-paced, high-performance environment.

Benefits

The expected base salary range for this position at hiring is $71,000 - $90,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.