CSV Engineer

Hybrid in Raritan, NJ, US • Posted 3 days ago • Updated 3 days ago

Contract W2

Contract Corp To Corp

Contract Independent

On-site

Depends on Experience

K-Tek Resourcing LLC

Fitment

Dice Job Match Score™

👾 Reticulating splines...

Job Details

Skills

CSV
GXP
Validation
Jira

Summary

Role - CSV Engineer Location - Raritan, NJ (Day-1 Onsite/Hybrid) Duration - Long Term Contract

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: 10411276
Position Id: 8870829
Posted 3 days ago

Company Info

About K-Tek Resourcing LLC

Vision

To be a trusted partner and advisor to our customers

Mission

At K-Tek we believe in understanding the specific needs of the customer and tailor-creating innovative solutions to meet these needs. We invest in our employees and customers. We build a relation of trust with our customers through empathy, solutions and being the first time right.

Who We Are & What We Do

K-Tek Resourcing is a consulting organization with offices in Houston TX and St. Paul, MN. It is supported by 2 global delivery centers, located in India. With its global employee strength of over 250, K-Tek has been supporting its clients for over 9 years. We have been consistently achieving a growth of 30% Year on Year. We have an extensive experience of working in domains including BFSI, Retail, Healthcare and Pharma, Oil & Gas, Travel & Hospitality and Insurance. The technologies we service are IT Infrastructure, Mobile Technologies, Cloud & Big Data Solutions. We understand the needs of our customers and provide them with customized solutions and resources with the tenet of being the "First Time Right".

Values

-Commitment to our customers success through Integrity

-Excellence through Quality

-Growth through customer value creation

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