5-7 years of experience in Computer System Validation (CSV) within regulated environments
2+ years of experience in System Development Lifecycle (SDLC)
Proven experience in the pharmaceutical, biotechnology, or medical device industries
Knowledge of FDA guidelines and GxP standards
Strong communication skills, both verbal and written
Proficient in writing and executing validation documentation
Team player with the ability to lead or work independently with remote teams
Responsibilities
Support validation activities ensuring adherence to FDA and GxP standards
Contribute to the development and execution of validation documentation
Review and approve test protocols and compliance reports
Engage in risk-based validation processes
Assist in multiple projects while managing changes and priorities
Collaborate with remote teams for validation tasks
Benefits
Opportunities for professional growth and development
Collaborative work environment with remote flexibility
Exposure to industry-leading best practices
Access to training in compliance and validation standards
Full Job Description
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:
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
