CSV Engineer

  • Jersey City, NJ
  • Posted 23 hours ago | Updated 23 hours ago

Overview

On Site
Depends on Experience
Full Time
Accepts corp to corp applications
100% Travel

Skills

Computerized System Validation
Defect Management
Auditing
Cloud Computing
Enterprise Resource Planning
Communication
Computer Science
MES
Manual Testing
Medical Devices
Data Integrity
Documentation
Pharmaceutics
GAMP
GxP
HP ALM
LIMS
Life Sciences
Organizational Skills
Writing

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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