
Specialist II, IT Validation Services
5 days ago
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. Read more:
Position Summary
The role supports the execution of Computer Systems Validation (CSV) activities for systems and applications within the Pharma GxP environment, under the guidance of the Validation Lead or Manager. The individual will collaborate with cross-functional teams and peers across BMS to ensure compliance with CSV standards and regulatory requirements.
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 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 to 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 bachelor's degree and 2-4 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): SAP, ServiceNow, Veeva, Regulatory Submission 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 and Understanding (desirable) of Electronic Records and Electronic Signature regulations, Data Integrity principles, GAMP and Agile methodologies.
•Works predominately within established procedures and 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.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
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.
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 Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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:
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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