Position Overview

The Software Implementation Engineer I assists/executes Software validation for Quality Management System’s or Production Software Job duties:
  • Generate Project Plans to identify strategies, roles/responsibilities, resource requirements, key milestones, timelines, etc. for software validation projects.
  • Follow SW validation procedure(s) to accomplish software validation or revalidation for Quality Management System (QMS) or Production Software (Equipment or Non-Equipment).
  • Collaborate with business process owners to develop specifications for systems to meet business requirements.
  • Work closely with the different teams involved to test the software provided by the vendor or in-house to verify it works as intended.
  • Generate master validations plans for software projects.
  • Generate/assist with risk assessments for software projects.
  • Generate, execute, and/or review SW validation protocols (Operation/Performance qualification protocols) and reports (verifies test cases are adequate, verifies executed protocols for GDP, etc.)
  • Coordinate user acceptance testing (UAT) activities and execution of validation protocols.
  • Generate software data migration plans and reports.
  • Generate software retirement plans and reports.
  • Assist with code review and unit testing reports.
  • Assist with training material and work instructions for users.
  • Manage completion of projects per SW validation master plans and ensure timely completion.
  • Provide expertise to SW owners with regards to identifying required level of validation for SW items.
  • Perform other duties and responsibilities as assigned.
    • Bachelor’s degree in Industrial Engineering.
    • English proficiency both written and verbal (80-85%).
    Desired Qualifications
    • Ability to translate regulation requirements into practical validation plans.
    • Ability to write and review SW validation documentation (validation plan, risk assessment, user/functional requirements, protocols, reports, etc.)
    • Successful experience working independently, effectively, and confidently in a team environment.
    • Ability to work with multiple associates and prioritize projects to meet deadlines.
    • Shows strong decision making and problem-solving skills.
    • Excellent written and verbal communication skills.
    • Proficient with MS Project, Word, Excel, and Outlook.