Senior CSV Validation Specialist

Bristol-Myers Squibb; United States; Hybrid; USD 120,000 - 170,000; Full time

Job summary

Bristol Myers Squibb seeks an experienced IT Validation professional to lead CSV activities across GxP applications, ensuring 'fit for use' before production releases. You will manage CSV projects and collaborate with IT Delivery and IT Quality to drive regulatory compliance.

The role requires strong knowledge of regulatory requirements, risk assessment, data integrity, and excellent English communication. Opportunity to contribute to patient-centric innovations within a global organization.

Qualifications

• B.E./B.Tech. or equivalent in computer science, engineering, life science.
• 7–9 years of experience in computer systems validation in the pharmaceutical industry, incl. 3+ years managing CSV projects.
• Experience validating systems such as CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, Regulatory Submission systems.
• General knowledge of IT applications, IT infrastructure, architecture of computer systems including cloud, networks, OS, databases and software tools.
• Good knowledge of IT testing practices and methodologies in Pharma GxP; experience with test management tools (ALM).
• Familiarity with test automation tools desired.
• Understanding of Electronic Records and Electronic Signature regulations, Data Integrity principles and GAMP.
• Excellent English verbal and written communication skills.

Responsibilities

• Participate in CSV activities across multiple GxP business areas to ensure 'fit for use' before release to production environment
• Participate in Qualification activities as it relates to infrastructure applications and hardware
• Conduct risk & impact assessments to determine the extent of validation and qualification requirements
• Implementation of organizational IT controls in accordance with applicable regulations and internal procedures
• Author CSV deliverables including but not limited to Plans & Summary Reports
• Support the SLC process as it relates to application validation and infrastructure qualification
• Identify opportunities for simplification, automation for CSV activities and partners with IT Delivery teams and IT Quality to implement
• Supports inspections and audits (internal and external).
• Conducts periodic reviews to ensure applications remain in a state of compliance
• Participates and represents IT Validation Services in problem management and audit remediation activities
• Provides regular status updates to one up manager and escalates any potential issues in a timely manner
• Support CSV staff across defined GxP business unit applications to ensure 'fit for use' before release to production environment

Skills

CSV validation

GxP compliance

Test management

English communication

Cloud & IT infra

Education

B.E./B.Tech. or equivalent in computer science, engineering, life science

Tools

ALM

ServiceNow

Veeva

Qumas

SAP

MES

Job description

Bristol Myers Squibb seeks an experienced IT Validation professional to lead CSV activities across GxP applications, ensuring 'fit for use' before production releases. You will manage CSV projects and collaborate with IT Delivery and IT Quality to drive regulatory compliance.

The role requires strong knowledge of regulatory requirements, risk assessment, data integrity, and excellent English communication. Opportunity to contribute to patient-centric innovations within a global organization.