Computer System Validation

2 days ago

Broadmeadows, Australia CSL Behring Full time

**Your Role**

The Computer System Validation Lead - Lab Execution Systems (LES), will be responsible for executing the Computerized System Validation (CSV) strategy and deliverables for global and Lab Execution Supporting Systems and related interfaces.

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

**Your Responsibilities**

Reporting to the Global CSV Lead you will:

- Implement LES CSV strategy across CSL
- Owner of the LES validation strategy in alignment with Quality
- Oversee the preparation, delivery, and execution of CSV deliverables for Lab Execution Systems
- Coordinate with Quality, Site and Global validation team to build alignment of LES validation expectations and maintain the validated state of LES platforms
- Develop processes and maintain platforms
- Manage System Development Lifecycle and validated state of LES platforms
- Accountable for the Periodic Review process for documentation and systems

**Your Experience**
- Bachelor's in Engineering, Computer Sciences, or similar field
- 7+ years' experience with CSV methodologies in Lab Execution Systems, operation IT, OT, or Automation position with a good understanding of pharma, biologics and chemistry
- Experience in writing, reviewing and executing CSV documents in a GAMP 5 CSV framework
- Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity principles
- Experience with Lab Execution Systems technologies that may include Laboratory Information Management Systems (LIMS), Chromatography Data Acquisition System (CDAS) and Laboratory Data Management systems
- Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5
- Experience using ALM platforms such as Kneat and Codebeamer to support CSV

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL.

**Do work that matters at CSL Behring**:

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