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Computer System Validation Lead
2 months ago
About the Role
The Computer System Validation Lead will be responsible for executing the Computerized System Validation (CSV) strategy and deliverables for global and Lab Execution Supporting Systems and related interfaces at CSL.
This role is part of a global function and can be based from our manufacturing sites.
Key Responsibilities
- Implement the CSV strategy across CSL
- Manage the CSV program for Lab Execution Systems and application interfaces
- 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
- Use validation lifecycle management applications such as Kneat to support CSV phases
Requirements
- 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
