Computer Validation Specialist – CSV for Regulated Systems

Compunnel, Inc.; New Jersey; On-site; USD 80,000 - 100,000; Full time

Job summary

A leading technology services provider is seeking a Computer Validation Specialist in New Jersey to ensure compliance with regulatory requirements and contribute to validation deliverables for computer systems. You will prepare and approve validation documents, conduct system integration testing, and maintain a validated state of systems throughout their lifecycle. Ideal candidates have a Bachelor's degree and 4+ years of experience in SDLC and software quality assurance, alongside knowledge of FDA regulations.

Qualifications

• 4+ years of SDLC experience, including system integration and validation testing.
• Experience in software quality assurance and manual testing.
• Knowledge of FDA regulatory requirements including 21 CFR Part 11.

Responsibilities

• Prepare and approve computer validation documents for CSV projects.
• Conduct system integration and validation testing for web applications.
• Ensure systems remain in a validated state throughout their lifecycle.

Skills

System Development Life Cycle (SDLC)

Software quality assurance

Communication skills

IT network infrastructure

Team collaboration

Education

Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field

Tools

Test automation tools

Trackwise

Empower

SAP

Job description

A leading technology services provider is seeking a Computer Validation Specialist in New Jersey to ensure compliance with regulatory requirements and contribute to validation deliverables for computer systems. You will prepare and approve validation documents, conduct system integration testing, and maintain a validated state of systems throughout their lifecycle. Ideal candidates have a Bachelor's degree and 4+ years of experience in SDLC and software quality assurance, alongside knowledge of FDA regulations.