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Sr. Software Validation Engineer : SDLC, FDA, ISO : Sandy, UT
11/15/2016 5:57:46 AM
Sr. Software Validation Engineer
B.S. or equivalent in computer science, engineering, life science or related field.
Minimum 8 years' experience with software validation in the medical/life science industry.
Previous experience leading computer system validation efforts.
Working knowledge of software development process, change management, GxPs, 21 CFR Part 11/Annex 11 and related regulations and 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 including Agile.
Excellent oral and written communication skills in English.