Computer System Validation (CSV) Lead – Lab Execution Systems (LES)

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Computer System Validation (CSV) Lead – Lab Execution Systems (LES)

Location: APAC, AU, Broadmeadows, CSL Behring Americas, US-IL, Kankakee, CSL Behring EMEA, DE, Marburg, US-PA, King of Prussia, UK – Maidenhead

Employment Type: Vollzeit

Posted: Yesterday

Application Deadline: 23. Mai 2025 (8 days remaining)

Job Requisition ID: R-253516

Your Role

The CSV Lead for Lab Execution Systems (LES) will execute the CSV strategy and deliverables for global Lab Execution Supporting Systems and related interfaces.

This role is part of a global team and can be based at manufacturing sites in Melbourne, Australia, or overseas.

Your Responsibilities

• Implement LES CSV strategy across CSL.
• Manage the CSV program for Lab Execution Systems and interfaces.
• Own the LES validation strategy in alignment with Quality.
• Oversee CSV deliverables for Lab Execution Systems.
• Coordinate with Quality and validation teams to ensure LES validation expectations and maintenance of validated systems.
• Develop and maintain validation processes and platforms.
• Manage System Development Lifecycle and validated state of LES platforms.
• Ensure periodic review of documentation and systems.
• Utilize validation lifecycle management tools like Kneat to support CSV phases.

Your Experience

• Bachelor\’s degree in Engineering, Computer Sciences, or similar.
• 7+ years\‘ experience with CSV methodologies in Lab Execution Systems, operation IT, OT, or Automation, with understanding of pharma, biologics, and chemistry.
• Experience in writing, reviewing, and executing CSV documents within a GAMP 5 framework.
• Knowledge of CSV, SDLC, and Data Integrity principles.
• Experience with Lab Execution Systems such as LIMS, CDAS, and Laboratory Data Management systems.
• Knowledge of industry standards like 21 CFR Part 11, Part 820, Annex 11, GAMP5.
• Experience with ALM platforms such as Kneat and Codebeamer.

Our Benefits

We prioritize your well-being. Learn more about how we care at CSL.

About CSL Behring

CSL Behring develops high-quality medicines for rare diseases, serving over 100 countries in areas like immunology, hematology, cardiovascular, respiratory, and transplant.

Our Commitment to Diversity

As a global organization with employees in 35+ countries, CSL values inclusion and belonging. Learn more about Inclusion & Belonging at CSL.

Join Us at CSL Behring!

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. Individuals with disabilities needing accommodations can click here.

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