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Software Validation Engineer
Independently authors and reviews software development and validation deliverables.
Conducts regulatory risk assessments.
Provide support to plan and develop software validations (IQ/OQ/PQ), risk analyses and applicable documentation in accordance with FDA and ISO harmonized standards.
Assist with the development of cGMP Validation Requirements, User Requirement Specification, Functional Requirement Specifications and Test Methods.
Evaluate and implement software applications in accordance with FDA and ISO harmonized standards following the applicable SDLC cycle.
Perform related duties as required.
B.S. or equivalent in computer science, engineering, life science or related field.
2-5 years’ experience with software validation in the medical/life science industry.
Working knowledge of software development process, change management, GxPs, 21 CFR Part 11/Annex 11 and related regulations & guidance’s.
Previous hands-on experience authoring computer system validation deliverables such as risk assessments, validation plans, test plans, test scripts and summary reports.
Understanding of software development methodologies and concepts.
Excellent oral and written communication skills in English.
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