CSV Validation Specialist (FDA/GxP)

Katalyst CRO; Raritan (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

Katalyst CRO is looking for a CSV Consultant in Raritan, NJ to support system validation activities in a regulated environment. The consultant will ensure compliance with FDA guidelines, contribute to validation documentation, and work within the System Development Lifecycle (SDLC). Candidates should have extensive experience in pharmaceutical or biotechnology industries, with a strong background in Computer System Validation (CSV) and knowledge of GxP standards. Excellent communication skills and ability to handle multiple projects are essential.

Qualifications

• 2+ years of experience with SDLC.
• 3+ years of experience in Computer System Validation (CSV).
• Experience in FDA regulated environments.

Responsibilities

• Support system validation activities ensuring compliance with FDA guidelines.
• Contribute to validation documentation and testing processes.
• Work within the System Development Lifecycle (SDLC).

Skills

Strong verbal and written communication skills

Team player

Ability to lead

Knowledge of FDA guidance and industry standards

Job description

Katalyst CRO is looking for a CSV Consultant in Raritan, NJ to support system validation activities in a regulated environment. The consultant will ensure compliance with FDA guidelines, contribute to validation documentation, and work within the System Development Lifecycle (SDLC). Candidates should have extensive experience in pharmaceutical or biotechnology industries, with a strong background in Computer System Validation (CSV) and knowledge of GxP standards. Excellent communication skills and ability to handle multiple projects are essential.