Senior Specialist, IT Validation Services

4 weeks ago

Hyderabad, India Bristol Myers Squibb Full time
Working with UsChallenging. 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 SummarySr. 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 teamKey Responsibilities

Functional and TechnicalParticipate in CSV activities for applications across multiple GxP business areas to ensure 'fit for use' before release to production environmentParticipate in Qualification activities as it relates to infrastructure applications and hardware in a timely mannerBe part of the team that Conducts risk & impact assessments to determine the extent of validation and qualification requirementsImplementation of organizational IT controls in accordance with applicable regulations and internal proceduresAuthor CSV deliverables including but not limited to Plans & Summary ReportsSupport the SLC process as it relates to application validation and infrastructure qualificationIdentifies opportunities for simplification, automation for CSV activities and partners with IT Delivery teams and IT Quality to implementSupports inspections and audits (internal and external).Conducts periodic reviews to ensure applications remain in a state of complianceParticipates and represents IT Validation Services in problem management and audit remediation activitiesProvides 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 & ExperienceB.E./B.Tech. or equivalent in computer science, engineering, life science fieldA minimum of 5-7 years of experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing CSV projectsExperience validating one or more of the following systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, eDC, Regulatory Submission systemsGeneral knowledge of IT applications, IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases, and software toolsGood 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 desirableGood understanding (mandatory) of Electronic Records and Electronic Signature regulations, Data Integrity principles and GAMP methodologyWorks predominately within established procedures. Ability to make decisions that impact own work and other groups/teams and works under minimal supervisionDemonstrates openness to learning and developing. Takes a responsibility for their own development and growthExcellent English verbal and written communication skills including the ability to write clear and precise documentation and deliver articulate presentationsOur 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

Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Why You Should ApplyAround 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.

  • Senior Quality Assurance Specialist

    2 months ago

    hyderabad, India Statistics & Data Corporation (SDC) Full time

    Senior Quality Assurance Specialist - Validation SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to...

  • Senior Specialist, IT Validation Services

    2 months ago

    Hyderabad, India Bristol Myers Squibb Full time

    Working with UsChallenging. 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...

  • Senior Specialist, IT Validation Services

    2 months ago

    Hyderabad, India Bristol Myers Squibb Full time

    Working with UsChallenging. 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...

  • 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...

  • Senior Specialist, IT Validation Services

    2 months ago

    Hyderabad, India Bristol Myers Squibb Full time

    Working with UsChallenging. 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...

  • Business Services Specialist

    5 days ago

    Hyderabad, India Randstad Offshore Services Full time

    JOB DESCRIPTIONRoles and Responsibilities:• Maintain compliant COI and Exhibit A extensions• Send recurring reminders to talent as required.• Process vendor letter requests.• Assist with follow-up for onboarding vendor documents.• Assist with audits on certain client requirements• TPV Extension - begin research• IC Extension - begin research•...

  • Business Services Specialist

    5 days ago

    Hyderabad, India Randstad Offshore Services Full time

    JOB DESCRIPTION Roles and Responsibilities:• Maintain compliant COI and Exhibit A extensions• Send recurring reminders to talent as required.• Process vendor letter requests.• Assist with follow-up for onboarding vendor documents.• Assist with audits on certain client requirements• TPV Extension - begin research• IC Extension - begin...

  • Business Services Specialist

    5 days ago

    Hyderabad, India Randstad Offshore Services Full time

    JOB DESCRIPTION Roles and Responsibilities:• Maintain compliant COI and Exhibit A extensions• Send recurring reminders to talent as required.• Process vendor letter requests.• Assist with follow-up for onboarding vendor documents.• Assist with audits on certain client requirements• TPV Extension - begin research• IC Extension - begin...

  • Senior Specialist

    2 weeks ago

    Hyderabad, India TJX Global IT - India Full time

    What you will discover ? Inclusive culture and career growth opportunities Global Organization which collaborates across U.S., Canada, Europe, Australia and India Challenging, collaborative, and team-based environment What you will do ? The TJX Global Sourcing and Procurement (GS&P) organization is the cornerstone of efficiency and excellence across our...

  • Senior Engineer, SSD Validation

    1 week ago

    Hyderabad, India Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR48811 Senior Engineer, SSD Validation Micron is...

  • Senior Engineer, SSD Validation

    1 week ago

    hyderabad, India Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR48811 Senior Engineer, SSD Validation Micron is...

  • Senior Management Specialist

    1 week ago

    Hyderabad, India TJX Global IT - India Full time

    What you will discover: Inclusive culture and career growth opportunities Global Organization which collaborates across U.S., Canada, Europe, Australia and India Challenging, collaborative, and team-based environment What you will do: The TJX Global Sourcing and Procurement (GS&P) organization is a trusted partner to our myriad of business functions. As a...

  • Associate Service Specialist

    2 months ago

    Hyderabad, India GRUNDFOS Full time

    Note that the location is in Visakhapatnam. As an Associate Service Specialist, you will apply broad expert technical knowledge and after-sales service to the regional/global market for Grundfos supplied services and solutions. Responsible for maintaining and developing service programs for products, service centers and partners and troubleshooting...

  • Associate Service Specialist

    1 month ago

    hyderabad, India GRUNDFOS Full time

    Note that the location is in Visakhapatnam. As an Associate Service Specialist, you will apply broad expert technical knowledge and after-sales service to the regional/global market for Grundfos supplied services and solutions. Responsible for maintaining and developing service programs for products, service centers and partners and troubleshooting...

  • Senior Integration Specialist

    6 days ago

    Hyderabad, India Viyona Fintech Full time

    Job Title: Senior API Integration Specialist Company: Viyona Fintech India Private Limited Location: [Hyderabad] Job Description: Viyona Fintech, a leading financial technology company, is seeking a highly-skilled and experienced Senior API Integration Specialist to join our dynamic team. The ideal candidate will have a strong background in API integration...

  • Operational Services – Data Onboarding Specialist

    4 weeks ago

    Hyderabad, India SS&C Technologies Holdings Full time

    Job Description SS&C Eze (Eze) is seeking a Data Onboarding specialist to join its Operational Services team in its Hyderabad office. We are looking for a candidate who has a proven track record in financial technology or a related discipline and can provide excellent service to our clients in the investment industry. Successful candidates will be highly...

  • Senior Specialist

    1 week ago

    Hyderabad/ Secunderabad, India LTIMindtree Full time

    Apply for Senior Specialist Software Engineering, LTIMindtree Ltd. in Hyderabad/ Secunderabad for Year of Experience on

  • Senior / Staff Hardware Validation Engineer

    1 month ago

    Hyderabad, India Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR51797 Senior / Staff Hardware Validation Engineer...

  • Senior / Staff Hardware Validation Engineer

    4 weeks ago

    hyderabad, India Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR51797 Senior / Staff Hardware Validation...

  • Systems Integration Senior Specialist

    5 days ago

    Hyderabad, India NTT DATA Services Full time

    Req ID:281059NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.We are currently seeking a Systems Integration Senior Specialist to join our team in Hyderabad, Telangana (IN-TG), India (IN).We are looking...