Senior Validation Engineer

Key Skills:

Roles and Responsibilities:

• Develop, write, and execute validation and qualification protocols for computer systems.
• Ensure compliance with FDA regulations, including 21 CFR Part 11.
• Collaborate with IT and business stakeholders to align validation requirements and documentation.
• Manage and prioritize multiple validation projects while meeting timelines.
• Maintain accurate documentation and records of all validation activities.
• Analyze validation results, identify gaps, and provide recommendations for improvement.
• Serve as a subject matter expert for computer system validation within the organization.
• Demonstrate a proactive and self-driven approach in managing responsibilities.

Skills Required:

• Strong expertise in Computer System Validation (CSV) within regulated industries.
• Experience in SAP system validation and compliance documentation.
• Knowledge of FDA regulations (21 CFR Part 11) and industry validation standards.
• Familiarity with test automation tools (e.g., TOSCA) and DevOps practices.
• Excellent analytical, problem-solving, and documentation skills.
• Ability to manage multiple validation projects simultaneously.
• Strong interpersonal skills to collaborate with IT, QA, and business stakeholders.
• Self-starter mindset with the ability to work independently under minimal supervision.

Education: