The Computer System Validation Lead for Lab Execution Systems will be responsible for executing the Computerized System Validation strategy and deliverables globally.
This role is part of a global function and can be based at our manufacturing sites in Melbourne, Australia or overseas.
Your Key Responsibilities
Reporting to the Global CSV Lead you will:
* Manage the Computerized System Validation program for Lab Execution Systems and application interfaces.
* Own 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 the System Development Lifecycle and validated state of LES platforms.
* Accountable for the Periodic Review process for documentation and systems.
* Utilize validation lifecycle management applications such as Kneat to support CSV phases.
Your Required Experience
* Bachelor's degree 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.
To be considered for this role, please submit your CV.