Demo

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences
Wilmington, DE Full Time
POSTED ON 9/3/2026
AVAILABLE BEFORE 10/3/2026
Roles & Responsibilities :
  • 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
  • uthoring of URS/FS, protocols, final reports, validation plan/report
  • High-level understanding of Veeva Vault suits
  • Risk-based testing aligned to CSA fundamentals
  • High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

Education & Experience :
  • 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

Salary.com Estimation for Computer System Validation Engineer in Wilmington, DE
$124,258 to $151,488
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

What is the career path for a Computer System Validation Engineer?

Sign up to receive alerts about other jobs on the Computer System Validation Engineer career path by checking the boxes next to the positions that interest you.
Income Estimation: 
$115,275 - $131,105
Income Estimation: 
$135,136 - $164,847
Income Estimation: 
$115,275 - $131,105
Income Estimation: 
$135,136 - $164,847
Employees: Get a Salary Increase
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

Job openings at Katalyst Healthcares and Lifesciences

Senior CQV Engineer
Apply
  • Katalyst Healthcares and Lifesciences Montpelier, VT
  • Job Description: We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for ph... more
  • Just Posted
Sr. Product Development Engineer
Apply
  • Katalyst Healthcares and Lifesciences Providence, RI
  • Roles & Responsibilities : uthor and maintain design control documentation for combination drug-device and biologic products, including Design History File... more
  • Just Posted
CSV Engineer
Apply
  • Katalyst Healthcares and Lifesciences Newark, DE
  • Job Summary: We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ... more
  • Just Posted
Senior Validation Engineer / Project Lead (Medical Devices)
Apply
  • Katalyst Healthcares and Lifesciences Salt Lake, UT
  • Summary: We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be respo... more
  • Just Posted
View More Jobs at Katalyst Healthcares and Lifesciences

Not the job you're looking for? Here are some other Computer System Validation Engineer jobs in the Wilmington, DE area that may be a better fit.

Oracle Database Migration Engineer / DBA - Oracle Autonomous Database (ADB)
Apply
  • Computer Task Group, Inc Middletown, NJ
  • CTG is seeking to fill an Oracle Database Migration Engineer / DBA – Oracle Autonomous Database (ADB) position for our client. Location: Dallas, TX or Midd... more
  • 7 Days Ago
Engineer II, Validation
Apply
  • Thermo Fisher Scientific Middletown, NJ
  • This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. P... more
  • 25 Days Ago
View More Jobs

AI Assistant is available now!

Feel free to start your new journey!