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Software Validation Engineer
Software Validation EngineerKatalyst CRO • Minneapolis, MN, US
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Software Validation Engineer

Software Validation Engineer

Katalyst CRO • Minneapolis, MN, US
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Overview

Join to apply for the Software Validation Engineer role at Katalyst CRO

Location : Plymouth, MN.

Responsibilities

  • 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.

Qualifications

  • 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.
  • Seniority level : Mid-Senior level.

    Employment type : Contract.

    Job function : Information Technology.

    Industries : Pharmaceutical Manufacturing.

    Notes

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