Job Details
Requirements:
- A BA/BS degree (Information Technology, Scientific, Business Administration or a related field is preferred)
- A minimum of five (5) years of related experience working in validation-related activities.
Desired:
- Knowledge of the regulations as they relate to Computer System Validation (e.g. 21 CFR Parts 11, 820, Medical Device Directive, ISO 13485)
- Demonstrated ownership of Computer System Validation (CSV) activities, including quality of deliverables and adherence to project timelines
- Results-driven with excellent organization, prioritization, and time management skills
- Excellent written and verbal communication skills, with a proven ability to effectively communicate and lead within a regulated environment
- Functional experience in a large ERP (e.g. SAP, ServiceMax) software environment is a plus
- Fundamental knowledge of a typical development cycle from requirement through development and testing, and through production implementation and support
- Hands-on experience testing: Javascript, jQuery, HTML5, CSS, and 3rd party API usage
- Experience with Microsoft C#, Microsoft .NET Core, ASP.NET, and ASP.NET Web API
- Experience with SQL Server Management Studio and SQL Profiler (preferred)
- The candidate should be self-motivated and be able to work without supervision