Software Validation Engineer – FDA

  • Portland, ME
  • This position has been filled

Our client is a leader in infectious diagnostic solutions. The Software Validation Engineer will be part of a remediation project contributing towards the company’s dedication to producing effective, high quality products that meet and exceed FDA standards.


  • Become the subject matter expert on computer system lifecycle, electronic records and governing FDA regulations.
  • Ensure software and electronic records meet FDA requirements
  • Implements best practices to improve data integrity, management and retention.
  • Collaborate with engineering, laboratory and business units to ensure software and processes comply with quality and regulatory requirements.
  • Collaborate with teams to develop and certify data documents to FDA regulations and company standards
  • Pilot new processes and procedures
  • Collaborate with all business units to develop and enforce SOP’s governing software, documents and data


  • Bachelor’s degree or similar work experience working with data in a highly regulated environment.
  • Experience working with cross functionally with non-technical groups
  • Database experience
  • Experience performing risk assessments, requirements gathering and delivering a finished product
  • Project Management experience, preferred.