Apply Now

Senior Computer System Validation (CSV) Engineer

Wilmington, DE, US • Posted 2 hours ago • Updated 2 hours ago

Contract W2

Contract Corp To Corp

Contract Independent

6 Months

Travel Required

On-site

Depends on Experience

Galaxy i Technologies, Inc.

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

🔢 Crunching numbers...

Job Details

Skills

Biostatistics
Clinical
Discovery
Medical Affairs
Pharmacovigilance
Regulatory Affairs
RPA GxP BOTs
R&D AI GxP

Summary

Job Title : Senior Computer System Validation (CSV) Engineer

Location :Wilmington, DE

JD :

Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor’s in Pharmacy
Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
Knowledge, Experience and Skills:
{
CORE CSV
 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
 Authoring of URS/FS, protocols, final reports, validation plan/report
 High-level understanding of Veeva Vault suits
 Risk-based testing aligned to CSA fundamentals
}
AND
{
R&D
 High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

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: 10374872
Position Id: 37182-43206-1793140556
Posted 2 hours ago

Company Info

About Galaxy i Technologies, Inc.

Galaxy i Technologies, Inc is a global consulting and IT services company that is known for its commitment to client satisfaction. Galaxy i Technologies is an information technology firm offering IT Consulting, Staff Augmentation, Software Development & Training and E-commerce Development. We help our Clients to implement these solutions through a variety of skilled consulting services like Application management, Implementation and Infrastructure management.

Galaxy i Technologies has a pool of highly skilled professionals who work through the life cycle of challenging and exciting projects, including System Analysis, Designing, Development, Implementation, Maintenance, Enhancements and Test Support to our Fortune 500 Corporations.

Careers

Go to company profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Wilmington, Delaware

•

Today

Job Title : Senior Computer System Validation (CSV) Engineer Location :Wilmington, DE Long term Contract JD : PLEASE NOTE The rates may be negotiable based on experience, education, geographic location, and other factors.. Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelors in Pharmacy Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills: { CORE CSV 21 CFR P

Contract, Third Party