Sr. CSV Engineer

Job Summary

Sr. CSV Engineer with 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments is sought. Ideal candidate must have expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management. Required experience includes testing tools like Client-ALM, JIRA, X-Ray, Agile methodologies, and global delivery models.

Roles & Responsibilities

• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.
• Subject matter expertise in areas such as Quality Management, Document Management, and Change Management.
• Establish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.
• Knowledge of various testing tools used throughout the pharmaceutical industry.
• Must have global client exposure and experience working in a global delivery model.
• Experience with Client-ALM, JIRA, X-Ray, and Agile methodologies.
• Responsible for developing, implementing, and managing process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet GxP and quality requirements on time and within budget to ensure compliance with regulatory expectations and SOPs.
• Establish and manage validation plans by aligning, coordinating, and supervising prioritization of activities against business needs.
• Set local procedures and templates for validation documentation and validation master plans.
• Create and maintain the overall board validation plan.
• Good communication and stakeholder management skills.