Senior Specialist, IT Validation Services

2 months ago

Hyderabad, India Bristol Myers Squibb Full time

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 rich in diversity. 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. Read more: careers.bms.com/working-with-us.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.


Position Summary

Sr. Specialist Computer System Validation (CSV) efforts for systems and applications in the pharmaceutical GxP space.

Collaborate with cross functional and multi-location IT Delivery teams, business users and IT Quality staff to ensure that CSV activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies.

Evaluate, propose, and implement technology solutions that improve digitization, compliance, and productivity. Serve as a CSV subject-matter-expert in support of internal and external regulatory inspections. Collaborate with peers across BMS on procedures relating to quality and computer system validation.

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


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


People Management:

  • 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 5-7 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, eDC, 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

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


Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

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