Remote SAP CSV Consultant (Computer Systems Validation Expert)

Job Description

Job Description

Contract Duration : 3–6 Months

Compensation : $40 / hour (Remote, W-2 or 1099)

Location : Remote, This is a USA based position only

About the Role

We are seeking a CSV Consultant (Computer Systems Validation Expert) to support validation activities in regulated industries such medical devices, and biotechnology. The ideal candidate will be an experienced professional with a strong command of FDA 21 CFR Part 11 , GAMP 5 , and GxP requirements. In addition to have Validation experience in SAP and understand it from the superuser perspective.

This role involves the full lifecycle of validation — from planning and writing detailed validation protocols to executing tests, documenting outcomes, and ensuring systems maintain data integrity and regulatory compliance.

Key Responsibilities

• Plan, write, and review validation protocols and related documentation for computer systems.
• Draft and maintain test scripts , IQ / OQ / PQ protocols , and validation reports .
• Conduct and document testing activities to verify systems function as intended and meet all regulatory and business requirements.
• Ensure data integrity and adherence to FDA 21 CFR Part 11 , GAMP 5 , and GxP standards.
• Collaborate with Quality Assurance, IT, and Regulatory Affairs teams to maintain compliance and support internal and external audits.
• Develop and maintain validation documentation , including validation plans, specifications, standard operating procedures (SOPs), and risk assessments.
• Support continuous improvement in validation and documentation processes.

Industries & Work Environments

Required Skills & Qualifications

Why Join Us

To Apply :

Please submit your resume and a brief summary of your validation and protocol writing experience, including systems or tools you’ve supported.