Specialist IT Validation Services

Bristol Myers Squibb; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Bristol Myers Squibb is seeking a Validation professional to support CSV activities for applications in the Pharma GxP space. You will work under the guidance of the Validation Lead/Manager, collaborating with peers to ensure systems are validated and compliant before go-live.

The role requires a bachelor's degree and 4–6 years of IT quality/validation experience, with knowledge of testing practices and experience with tools like ALM. Strong written and spoken English are essential.

Qualifications

• 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 systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, REMS and Regulatory systems.
• Good knowledge of IT testing practices and methodologies in Pharma GxP space and test management tools.

Responsibilities

• Support execution of CSV activities for applications across multiple GxP business areas to ensure ‘fit for use’ before release to production environment.
• Support execution of Qualification activities related 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 plans and Summary Reports.
• Review change tickets and ensure alignment with change management processes.

Skills

IT Quality

CSV validation

Documentation

Communication skills

Education

Bachelor's degree

Tools

ALM

Job description

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.

If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!

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.

• Conducts 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.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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 accommodations/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 our 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.