Job Description

  • As necessary modify/create Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity Required
  • Work closely with the Validation Lead and Business Analyst to ensure test scripts are ready for OQ and PQ.
  • Work with business representatives to ensure the test cases reflect business rules and processes
  • Have the ability to work with IT management, business analysts and technical staff.
  • Be a good team player, able to meet deadlines and handle changing priorities.
  • Be able to prepare reports on defects and problems that arise during system testing.
  • Be responsible for assuring a system/application meets its requirements as outlined in system specification per process defined in the Validation Plan for the project.
  • The candidate should:
  • The candidate responsibilities include mainly writing test cases based on functional specifications and executing test scripts to ensure the system release functions as expected by company.
  • Demonstrate attention to detail and accountability.
  • Identify and escalate, as necessary project risks and issues to the Validation Lead and/or Project Manager.
  • Have solid oral and written communication skills and teamwork skills.
  • Have strong judgment capabilities to clarify requirements when necessary.
  • Have solid experience working with validated systems
  • Revise test cases as necessary based on project team feedback.
  • Other duties include: run validation test scripts as assigned, assist with preparing and updating validation documentation including specifications, defects, etc.


  1. Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
  2. Highly skilled in Computerized System testing and validation in the healthcare industry.
  3. The candidate must have experience with Quality Center and understand the SDLC processes.
  4. Experience with TrackWise is a highly desired skill set. Additional skills required include developing operational and performance based test scripts from functional specifications.
  5. Knowledge of GxP regulations (e.g. 21 CFR Part 11,etc.)
  6. Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills.
  7. Excellent communication including written, verbal, and listening skills.
  8. Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.