Validation Manager (Software)

PersolKelly

  • Malaysia
  • Permanent
  • Full-time
  • 2 months ago
Responsibilities: Lead the design, development, and implementation of technical solutions for complex projects. Responsible for aiding in Quality Management and overseeing site/plant validations encompassing processes,equipment, software and test methods. Analyze and interpret data and information, perform continuous integration, monitor the operation of completeautomation systems. Perform troubleshooting of automation systems if necessary. Build and innovate automation and testing frameworks. Devise testing and validation workflows to ensure that product meets company requirements. Improve the efficiency of current testing procedures. Manage and maintain the documentation of testing procedure and results to ensure traceability. Manage the plant Validation Master Plan (VMP) for sites/plants, conducting periodic process review and re-validation as needed. Design validation tests to verify that performance of new hardware and software features is met. Perform validation testing of new hardware and software features providing detailed feedback and analysis ofresults. Collaborate with the hardware development team to design and create new innovative features andimprovements based on your observations and experience. Develop and optimize instrument parameters for the ultimate in performance. Create custom test samples for validating system performance. Track all changes in hardware and software and validate the implementation. Provide bug reports and feedback to the software team. Work on hardware troubleshooting/upgrades Maintain and present status reports on scheduled projects. Responsible for overall management of Process Validation Program, Stability Program and PFMEA program. Coordinate, monitor and execute the Process Validation Program and Stability Program Be a validation independent reviewer and technical independent reviewer for process validation protocol &report. Review process validation data generated and performed statistical analysis where appropriate. Requirements: Degree in Electrical & Electronic Engineering, Computer Science or equivalent. Knowledge of statistics is desirable. Possess 10 years of related experience reliability testing and design analysis Possess a wide breadth of knowledge across multiple engineering fields (mechanical, electrical, electronics andsoftware). Attention to detail and have a no-compromise approach to testing and documentation. Have the capability to identify problems, troubleshoot (simple) issues, and convey technical issues toengineers. Assertive and capable of making arguments based on test data.

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