CSV Engineer

  • Jersey City, NJ
  • Posted 18 hours ago | Updated 18 hours ago

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 12 Month(s)
100% Travel

Skills

GxP
HP ALM
Defect Management
Medical Devices
Auditing
GAMP
LIMS
MES
HPALM
Manual Testing
GAMP 5
FDA 21 CFR Part 11
Annex 11

Job Details

Role: Computer System Validation Engineer

Location: New Jersey

Exp: 12+ years

Required Skills & Qualifications
Bachelor s degree in computer science, Engineering, Life Sciences, or related field.
Need 12+ years of experience.
3 7 years of experience in CSV within pharmaceutical, biotech, or medical device industries.
Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines.
Experience with ERP, LIMS, MES, or other GxP systems.
Extensive Experience in HPALM with Manual testing.
Deep knowledge in Defect Management Life cycle.
Proficient in writing validation protocols, reports, and SOPs.
Strong communication, documentation, and organizational skills.

Preferred Qualifications
Experience with cloud-based GxP systems.
Familiarity with data integrity principles.
Previous experience in audit preparation and support.

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