Senior Specialist, IT Validation Services

Responsibilities

• Lead Computer System Validation (CSV) efforts for applications and systems within the pharmaceutical GxP space
• Collaborate with cross-functional IT Delivery teams, business users, and IT Quality staff to ensure CSV activities align with internal procedures
• Conduct risk and impact assessments to determine validation and qualification requirements
• Author critical CSV deliverables, including validation plans and summary reports
• Implement organizational IT controls in compliance with applicable regulations
• Identify opportunities for automation and simplification of CSV activities
• Support internal and external regulatory inspections and audits
• Perform periodic reviews to ensure applications maintain a continuous state of compliance
• Serve as a CSV subject-matter expert during problem management and audit remediation activities

Requirements

• B.E./B.Tech. or equivalent degree in Computer Science, Engineering, or a Life Science field
• 7-9 years of experience in computer systems validation within the pharmaceutical industry
• Minimum of 3 years of experience managing CSV projects
• Strong understanding of GAMP methodology and Data Integrity principles
• Proven experience with IT testing methodologies and test management tools (e.g., ALM)
• Deep knowledge of Electronic Records and Electronic Signature regulations
• Excellent English verbal and written communication skills for technical documentation and presentations

Preferred Qualifications

• Experience validating systems such as CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, or Regulatory Submission systems
• Familiarity with test automation tools
• General knowledge of IT infrastructure, including cloud, networks, operating systems, and databases

About the Company

Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients' lives through science. We harness the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery and enhance patient care.