Validation Manager (Software)

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 complete automation 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 of results.
• Collaborate with the hardware development team to design and create new innovative features and improvements 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.

• 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 and software).
• 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 to engineers.
• Assertive and capable of making arguments based on test data.