Description

You will own and execute validation activities for regulated computer systems, ensuring strict compliance with FDA regulations.

This role is on-site.

Responsibilities

• Develop, write, and execute validation and qualification protocols for computer systems.
• Manage multiple validation projects simultaneously while meeting established timelines.
• Analyze validation results, identify gaps, and provide recommendations for system improvements.
• Maintain accurate documentation and records of all validation activities.

Required Skills

• Strong expertise in Computer System Validation (CSV) within regulated industries.
• Experience in SAP system validation and compliance documentation.
• Knowledge of FDA regulations, specifically 21 CFR Part 11.
• Familiarity with test automation tools such as TOSCA.
• Understanding of DevOps practices.
• 6+ years of relevant professional experience.
• Excellent analytical, problem-solving, and documentation skills.

Preferred Skills

• Strong interpersonal skills for collaboration with IT, QA, and business stakeholders.

Key Skills

Education

Any Graduate