IT CSV Analyst - Remote

Overview

We are seeking a detail-oriented and experienced IT CSV Analyst to support the validation of computerized systems in compliance with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other GxP standards.

In Short

• Develop and maintain Computer System Validation (CSV) documentation.
• Work closely with IT, QA, business stakeholders, and vendors.
• Review and assess change controls and deviations.
• Ensure compliance with GAMP 5 guidelines.
• Support audits and inspections by regulatory authorities.
• Participate in system implementation projects.
• Maintain documentation and validation lifecycle.
• Conduct periodic reviews of validated systems.

Requirements

• Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or related field.
• Minimum 3–5 years of experience in IT CSV, QA, or compliance roles.
• Strong knowledge of GxP regulations.
• Familiarity with SDLC and validation methodologies.
• Experience with GxP-regulated systems is a plus.
• Strong documentation, analytical, and communication skills.
• Ability to work independently and in teams.

Benefits

• Mostly remote work with occasional visits to Waltham, MA.
• Some travel may be required for implementations or audits.