Software System Validation Professional

Vor 5 Tagen

Bern, Bern, Schweiz CSL Vollzeit
About the Role

The Computer System Validation Lead – Lab Execution Systems will be responsible for developing and executing a comprehensive strategy for Computerized System Validation (CSV) of global and Lab Execution Supporting Systems.

This role is part of a global function and can be based from various locations. Reporting to the Global CSV Lead, you will oversee the preparation, delivery, and execution of CSV deliverables for Lab Execution Systems.

Your Key Responsibilities:

  • Manage the CSV program for Lab Execution Systems and application interfaces
  • Develop and maintain the LES validation strategy in alignment with Quality
  • Coordinate with Quality, Site, and Global validation teams to ensure alignment of LES validation expectations
  • Oversee the maintenance of 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
About You

We are seeking an experienced professional with a Bachelor's degree in Engineering, Computer Sciences, or a similar field. The ideal candidate will have at least 7 years' experience with CSV methodologies in Lab Execution Systems, operation IT, OT, or Automation position.

Required Skills and Qualifications:

  • Experience with 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

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