Lead CSA & CSV Engineer - GxP Compliance

Partner Company; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Partner Company is seeking a skilled professional to lead the development and execution of CSV and CSA strategies, ensuring GxP-regulated systems meet FDA, ISO, and global regulatory requirements through risk-based validation and documentation.

You will collaborate with IT, Quality, Engineering, and Manufacturing teams to support compliant system implementations and lifecycle management across the organization.

Responsibilities

• Lead the development and execution of Computer System Validation (CSV) and Computer Software Assurance (CSA) strategies, plans, and protocols.
• Ensure GxP-regulated systems comply with FDA, ISO, and other global regulatory requirements through risk-based validation and documentation.
• Collaborate with IT, Quality, Engineering, and Manufacturing teams to support compliant system implementations and lifecycle management.

Job description

Partner Company is seeking a skilled professional to lead the development and execution of CSV and CSA strategies, ensuring GxP-regulated systems meet FDA, ISO, and global regulatory requirements through risk-based validation and documentation.

You will collaborate with IT, Quality, Engineering, and Manufacturing teams to support compliant system implementations and lifecycle management across the organization.