Sr Computer System Validation Engineer/Business Analyst

Sr RBV and VM Technical Business System Analyst

• Lead and execute system analysis and validation efforts following CSA and GAMP 5 methodologies.
• Handson experience performing Veeva configurations, creating reports and dashboard
• Develop and manage Veeva validation documentation including requirements, test scripts, traceability, and risk assessments.
• Collaborate with global and virtual teams to define system requirements and ensure successful implementation.
• Perform gap analyses, identify risks, and recommend mitigation strategies to ensure compliance and operational efficiency.
• Work closely with IT, Quality, and Business stakeholders to ensure alignment between technical solutions and business needs.
• Serve as a subject matter expert in system validation, providing guidance and mentorship to project teams.
• Manage multiple initiatives concurrently, ensuring on-time delivery and adherence to regulatory standards.
• Support ongoing process improvements to enhance system reliability and compliance posture.

Must Have Skills:

• Proven experience in CSA and GAMP 5 implementation.
• Strong knowledge of Veeva validation management and Veeva configurations.
• Excellent analytical and problem-solving skills.
• Strong verbal and written communication abilities.
• Demonstrated ability to work effectively with global, virtual teams.
• Experience working independently, guiding project teams, and making informed decisions.

Nice to Have Skills:

• Prior hands-on experience with CSA and GAMP 5 implementation projects.
• Experience implementing OpenAI or AI-driven use cases in business systems.
• Proven ability to manage multiple priorities and deliver results under tight timelines.
• Strong presentation and public speaking skills.
• Experience collaborating with Product Owners, Service Owners, and delivery teams to ensure service quality and resolve escalations.
• Experience working with cross-functional teams—including product management, design, and QA—to deliver compliant, high-quality solutions.