CSV Consultant

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

Job Summary

• CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
• The role involves working within the System Development Lifecycle (SDLC) and contributing to validation documentation and testing processes.
• Strong verbal and written communication skills

Experience & Qualifications

• Experience in the pharmaceutical, biotechnology, or medical device industry
• 2+ years of experience with System Development Lifecycle (SDLC)
• 3+ years of experience in Computer System Validation (CSV)
• Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation
• Knowledge of FDA guidance and industry standards (e.g., GAMP)
• Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously
• Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports)
• Experience in reviewing system test and user acceptance test (UAT) scripts, Traceability Matrix, and Design Specifications
• Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT scripts, and test procedures