CSV Engineer

• Ensure that all software and hardware systems meet regulatory requirements (e.g., FDA, EMA, GxP, 21 CFR Part 11).
• Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports.

Key Responsibilities:

1. Computer System Validation (CSV) Activities:

• Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform risk assessments and develop validation strategies for computer systems and software.
• Ensure validation efforts are in compliance with FDA, GxP (Good Laboratory Practice, Good Manufacturing Practice), and other regulatory requirements.
• Work closely with cross-functional teams to identify validation needs and implement validation processes.
• Manage the full lifecycle of validation efforts, from planning through execution and close-out.

2. Documentation and Compliance:

• Prepare and maintain comprehensive validation documentation, including protocols, test scripts, and reports.
• Review and approve validation-related documents and records to ensure compliance with internal procedures and external regulatory standards.
• Perform Change Control assessments and ensure proper documentation of changes made to validated systems.

3. Collaboration and Support:

• Work with IT, Quality Assurance, and other departments to ensure timely execution of validation activities.
• Provide technical support for system implementations, upgrades, and migrations.
• Act as a subject matter expert (SME) on CSV-related topics and regulatory requirements.

4. Continuous Improvement:

• Identify opportunities for process improvement and implement best practices in validation efforts.
• Stay updated on industry trends, regulatory updates, and best practices in computer system validation.