Computer System Validation (CSV) Specialist

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Computer System Validation (CSV) Specialist

Job Summary

We are seeking a Computer System Validation (CSV) Specialist with more than five years of experience in the biotech industry to support validation activities for regulated computerized systems. The ideal candidate has hands-on experience using Kneat and is well-versed in CSV requirements within GMP environments.

Key Responsibilities

Support planning, execution, and documentation of computer system validation activities

Develop, execute, and review CSV lifecycle documentation

Ensure computerized systems comply with GMP and regulatory requirements

Support risk assessments, testing, and validation reports

Collaborate with IT, Quality, and Engineering teams

Required Qualifications

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

More than 5 years of experience in Computer System Validation within biotech or pharmaceutical environments

Hands-on experience using Kneat

Strong knowledge of GMP, CSV, and data integrity requirements

Full-time