Computer System Validation (CSV) Expert - Remote

Overview

Tenthpin Solutions is looking for an experienced, pro-active and highly skilled CSV Expert to join our rapidly growing organization. The successful applicant will have a passion for creating innovative solutions that add substantial value to our clients and will contribute to our reputation as one of the recent success stories within the Consulting and Technology industry.

In Short

• Develop and implement CSV strategies in compliance with GxP requirements.
• Support GxP & HIPAA compliance for product development.
• Ensure data security and integrity in validated systems.
• Oversee qualification processes and document activities.
• Facilitate audits and inspections for compliance.
• Maintain compliance in change control for system changes.
• Recommend and implement continuous improvements.
• Collaborate with teams to ensure quality in software solutions.

Requirements

• Degree in computer science, engineering or related field.
• 5+ years of experience in CSV / GxP.
• Deep understanding of GxP regulations and HIPAA requirements.
• Knowledge of data integrity principles and security practices.
• Experience in regulatory audits and inspections.
• Strong analytical skills and problem-solving mindset.
• High attention to detail for compliance accuracy.
• Excellent communication and collaboration skills.
• Fluent in English; additional languages are a plus.

Benefits

• Competitive salary and benefits package.
• Exceptional work environment.
• Long-term career development opportunities.
• Supportive team culture.
• Innovative and collaborative workplace.