Software Validation EngineerKatalyst CRO • Minneapolis, MN, US
Software Validation Engineer
Katalyst CRO • Minneapolis, MN, US
9 days ago
Job type
- Full-time
Job descriptionBachelor'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.
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
Seniority level : Mid-Senior level.
Employment type : Contract.
Job function : Information Technology.
Industries : Pharmaceutical Manufacturing.
Notes
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Validation Engineer • Minneapolis, MN, US