Specialist, IT Validation Services

Bristol-Myers Squibb Co; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Bristol Myers Squibb is seeking a Specialist, IT Validation Services in Hyderabad to support CSV activities for Pharma GxP systems, collaborating with the Validation Lead and cross-functional teams. The role emphasizes risk assessment, creating validated deliverables such as validation plans and summaries, and ensuring compliance through change management processes.

The ideal candidate has a bachelor’s degree and 4–6 years in IT quality or CSV, with knowledge of ALM or similar tools and strong

Qualifications

• Bachelor's degree in IT or related field.
• 4–6 years in IT Quality, CSV or related area.
• Familiarity with Pharma GxP validation processes.

Responsibilities

• Support execution of CSV activities for applications across GxP areas.
• Support qualification activities for infrastructure and hardware.
• Assist validation lead with risk and impact assessments.
• Author CSV deliverables including Plans & Summary Reports.
• Review changes and ensure compliance through change management.

Skills

IT Quality

CSV

Documentation

Communication

Independent work

Education

Bachelor's degree

Tools

ALM

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"- a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Job Description Supports the execution of Computer Systems Validation (CSV) activities for systems and applications in Pharma GxP space under the guidance of Validation Lead/ Manager. Collaborate with peers across BMS on CSV activities. At BMS, digital innovation and Information Technology are central to our vision of transforming patients’ lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care.

Key Responsibilities

• Support execution of CSV activities for applications across multiple GxP business areas the to ensure "fit for use" before release to production environment
• Support execution of Qualification activities as it relates to infrastructure applications and hardware in a timely manner
• Support validation lead in conducting risk & impact assessment to determine the extent of validation and qualification
• Author CSV deliverables including but not limited Plans & Summary Reports
• Support the SDLC process as it relates to application validation and infrastructure qualification
• Review and approve change tickets for applications and ensure alignment with change management process.
• Conduct periodic reviews of applications to ensure applications remain in a state of compliance.
• Provides regular status updates to one up manager and escalates any potential issues in a timely manner

Qualifications & Experience

• Minimum Bachelors degree and 4-6 years of experience in IT Quality, Computer System Validation and/or related field.
• Experience supporting validation of one or more of the following systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, REMS and Regulatory systems.
• Experience in change management process
• General knowledge (desirable) of IT applications, IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases, and software tools
• Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of test management tools like ALM etc.
• Familiarity with test automation tools desirable
• Understanding (desirable) of Electronic Records and Electronic Signature regulations, Data Integrity principles, GAMP and Agile methodologies
• Works predominately within established procedures
• Ability to work under minimal supervision
• Demonstrates openness to learning and developing.
• Takes a responsibility for their own development and growth
• Good English verbal and written communication skills including the ability to write clear and precise documentation.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during this application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605601 : Specialist, IT Validation Services Data Privacy Link

We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.