Senior Specialist

Biopharma Careers; Hyderabad; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior CSV Specialist to validate pharmaceutical IT systems, ensure data integrity, and support regulatory audits. The role spans multiple GxP applications, requiring strong collaboration with IT and QA teams to maintain compliant, fit-for-use environments.

The position emphasizes risk assessment, control implementation, and the creation of validation deliverables. A background in CS validation within pharma, plus ALM familiarity, is desired for success.

Qualifications

• B.E./B.Tech. or equivalent in computer science, engineering, life science field.
• 7–9 years of CS validation experience in pharma, with 3+ years managing CSV projects.
• Experience validating systems like CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, or regulatory systems.
• General knowledge of IT applications, infrastructure, cloud, networks, OS, databases, and software tools.
• Solid knowledge of IT testing practices and tools (ALM).
• Familiarity with test automation tools is desirable.
• Understanding of Electronic Records and Electronic Signature regulations, Data Integrity, and GAMP.

Responsibilities

• Conduct CSV activities for multiple GxP areas to ensure fit-for-use before production release.
• Participate in qualification for infrastructure applications and hardware.
• Perform risk and impact assessments to set the validation scope.
• Implement IT controls per regulations and internal procedures.
• Author CSV deliverables including Plans and Summary Reports.
• Support the SLC process related to application validation and infrastructure qualification.
• Identify opportunities to simplify and automate CSV activities with IT teams.
• Support inspections and audits (internal and external).
• Conduct periodic reviews to ensure ongoing compliance.
• Represent IT Validation Services in problem management and audit remediation.

Skills

CSV activities

Risk assessment

IT controls

CSV deliverables

SLC process

Automation opportunities

Audits

Documentation

Education

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

Tools

ALM

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Functional and Technical

• Participate in CSV activities for applications 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 in a timely manner
• Be part of the team that Conducts 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
• Identifies 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

Qualifications & Experience

• B.E./B.Tech. or equivalent in computer science, engineering, life science field
• A minimum of 7-9 years of experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing CSV projects
• Experience validating one or more of the following systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, Regulatory Submission systems
• General knowledge 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
• Good understanding (mandatory) of Electronic Records and Electronic Signature regulations, Data Integrity principles and GAMP methodology
• Works predominately within established procedures. Ability to make decisions that impact own work and other groups/teams and works under minimal supervision
• Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth
• Excellent English verbal and written communication skills including the ability to write clear and precise documentation and deliver articulate presentations

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

• Site-essential roles require 100% of shifts onsite at your assigned facility.
• Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
• For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail] . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1605372 : Senior Specialist