Software Validation Engineer
Software Validation Engineer
Posted on :
04-09-2025
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1 Vacancy
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Job Description
Roles & Responsibilities:
- Bachelors 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.
Employment Type
Full-time
Key Skills
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