CSV Engineer

Raritan, NJ, US • Posted 1 day ago • Updated 1 day ago

Full Time

On-site

Depends on Experience

Sharpedge Solutions

Fitment

Dice Job Match Score™

👾 Reticulating splines...

Job Details

Skills

Computer System Validation
CVS

Summary

Role - CSV Engineer
Location - Raritan, NJ(Hybrid)

Job Details:
10+ years experience in Computer System Validation or Quality management or Business Analysis in GxP application area
Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.
Developing validation strategy for projects
Providing audit support and support Application Lifecycle Management
Managing/guiding/overseeing periodic checks
Ability to guide cross-functional teams and mentor junior staff
Broad experience in Computer System Validation (CSV) and testing
Acquainted with Good Clinical Practices (Google Cloud Platform) regulatory requirements and FDA 21 CFR Part 11
Clear written and verbal communication, especially for technical documentation
Acquainted with both the agile and waterfall software development methodology
Solid understanding of the fundamentals of iterative and incremental software development
Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems
Skilled in project planning, execution and minimal rework strategies
Capable of risk identification and mitigation, especially in regulated environments
Strong Analytical and Problem solving

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10115377
Position Id: 8870657
Posted 1 day ago

Company Info

About Sharpedge Solutions

Sharpedge Solutions is a leading technology product development and services company providing cutting-edge solutions to various industries across the spectrum. We offer broad-scale cost-effective technical solutions through our Onsite-Offshore model ranging from design, architecture, development to implementation and support. Sharpedge offers IT expertise in multiple verticals such as Insurance, Telecom, Healthcare, Banking & Financial Services, Retail, and Manufacturing.

Our services comprise of building, re-engineering, enhancing, and supporting enterprise applications. Sharpedge's seasoned professionals and innovative products ensure our clients stay ahead of the curve in the fast-evolving technology market.

With over 20 years of successful operations and exceptional growth history, we take great pride in delivering quality solutions that improve performance and reduce IT costs while increasing the return organizations get from their investments and assets.

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