Software Validation Engineer

cGxPServe

  • Plymouth, MN
  • Permanent
  • Full-time
  • 23 hours ago
  • Apply easily
Roles & Responsibilities:
  • Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field.
  • Minimum 5-8 years of experience in software validation, preferably within
the medical device, pharmaceutical, or regulated healthcare industries. * Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles.
  • Experience in handling SW development and verification tools.
  • Good exposure to FDA regulations (21 CFR Part 11, Part 820), ISO 13485, EU MDR, GAMP 5, and other relevant standards for software lifecycle and validation.
  • Experience with computerized system validation (CSV) approaches for non-product applications.
  • Proficiency in authoring validation documents as per SOP or work instruction.
  • Responsible for SW Validation planning, requirement gathering, Risk assessment, protocol development and test execution.
  • Work with cross functional team and SME to understand the intended use and prepare the above documentation.

cGxPServe