CSV Engineer

POSITION PURPOSE

The CSV Engineer is responsible for ensuring the effective execution, review, and continuous improvement of all Computer System Validation (CSV) activities in alignment with corporate and regulatory standards. This self-driven professional will manage the validation lifecycle of GxP computerized systems, ensuring they remain compliant, reliable, and audit-ready.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To excel in this position, a CSV Engineer must satisfactorily perform the following essential duties. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Prepare, execute, and report on validation deliverables for GxP computerized systems at the site.
• Ensure all validation activities and deliverables adhere to relevant regulatory requirements (e.g., FDA, EMA) and internal company standards.
• Maintain the validated state of all GxP computerized systems, ensuring ongoing compliance.
• Oversee the end-to-end implementation of assigned projects, track progress, manage escalations, and follow up on critical tasks.
• Support self-inspection and remediation activities related to GxP computerized systems to address potential gaps and ensure compliance.
• Conduct regular periodic reviews of all GxP computerized systems, verifying sustained compliance and performance.
• Contribute to the revision, development, and implementation of CSV procedures and standards.
• Manage associated Quality Management System (QMS) activities, including timely completion of Change Controls, Deviations, Investigations, and CAPAs related to computerized systems.
• Review validation protocols, QMS documentation, and CSV deliverables for accuracy, completeness, and compliance.
• Lead site readiness activities for internal and external audits, actively participating in audit processes as required.
• Deliver training on CSV topics and procedures to cross-functional team (CFT) members.
• Maintain an up-to-date inventory of all GxP computerized systems at the site.
• Perform other related duties as assigned.

QUALIFICATIONS

Knowledge:

• In-depth understanding of applicable regulatory requirements and industry best practices for GxP computerized systems (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5).

Skills and Abilities:

• Proven ability to deliver and sustain CSV compliance activities.
• Strong organizational, analytical, and problem-solving skills.
• Ability to work autonomously and provide direction to others as needed.