Senior Specialist ITVS Digital Validation

Responsibilities

• Drive digital validation projects to optimize Computer Systems Validation (CSV) processes.
• Implement agentic AI and AI/ML validation processes for GxP enterprise applications.
• Develop and maintain documentation for AI/ML models, algorithms, and processes.
• Leverage Large Language Models (LLMs) to integrate and fine-tune conversational AI solutions.
• Participate in CSV activities and qualification activities for infrastructure and hardware.
• Conduct risk and impact assessments to determine validation and qualification requirements.
• Author CSV deliverables, including validation plans and summary reports.
• Identify opportunities for automation and simplification in CSV activities.
• Support inspections, audits, and periodic compliance reviews.

Requirements

• B.E./B.Tech. or equivalent in Computer Science, Engineering, or a Life Science field.
• 5-7 years of experience in Computer Systems Validation (CSV).
• Strong technical development skills, including Python coding.
• Solid knowledge of AI/ML capabilities and implementation.
• General knowledge of IT infrastructure, architecture, cloud, networks, and databases.
• Excellent English verbal and written communication skills for precise documentation.

Preferred Qualifications

• Familiarity with test automation tools.
• Experience working within established regulatory procedures and GxP environments.

About the Company

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail against serious diseases. We foster a culture of innovation, inclusion, and integrity to transform patients' lives through science.