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

Job Description:

The main objective of this role is to support IT-related activities associated for the maintenance of computerized systems in a compliance state. Activities will be related to the execution of compliance related tasks supporting Information Technology, Laboratories, Manufacturing, Inspection, Packaging, Facilities and Utilities, as applicable. This position will be responsible to monitor and improve the compliance of computerized systems by identifying, investigating, developing, and implementing remediation actions and initiatives to enhance system administration, data integrity compliance, CSV activities, and system’s incidents resolution. Resource will be responsible of submitting Change Controls, SOPs Periodic Review, Audit Trail Periodic Review Reporting, User Access Review Reporting. Also, ensure that cGMP’s related IT Compliance are properly maintained in accordance with all Federal, State and Corporate Regulations and therefore, supporting BMS’s business goals. This position must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Roles and Responsibilities:

• Conduct thorough investigations for computerized and automated systems supporting Manati Operations utilizing root cause analysis tools.
• Act as the Computerized Systems SME for the site during investigation events, and assure all systems follow Federal, State and Corporate Regulations supporting BMS’s business goals.
• Serve as the lead investigator for IT deviation assessments, and root cause investigations with the ability to summarize progress to Sr. Management, collect information from the triage team, and gather necessary supporting data from technical and quality teams outside the Information Technology area.
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness for assigned investigations. Assess potential impact and risk to product (or process) associated to the implementation of changes from an investigation assuring proper mitigation strategies are implemented for computerized/automated systems.
• Initiate change control documentation for those changes to computerized/automated systems. Identify functional area SMEs to perform impact assessments as part of the change management process.
• Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
• Provide technical support and complete technical reports in support to manufacturing investigations requiring information related to computerized/ automated systems.
• Lead deviation investigation defense during internal/external audits and site inspections for Computerized/Automated systems compliance related inquiries.
• Handle complex issues and solve problems with minimal guidance. Manage teams to support more complex investigations, as required by the site leadership.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• Execute the IT SOPs Periodic Review program, Audit Trail Periodic Review Reporting, User Access Review Reporting.
• Fosters creative problem solving and provides technical guidance on computerized systems situations to Quality staff.
• Assures timely closure of investigations, audit observations, CAPAs and/or change control for quality computerized/automated systems.
• Coordinate with suppliers of hardware/software and services for quality computerized systems problem resolution.
• Employ lean manufacturing / six sigma principles to continuously improve products, processes and computerized/automated systems.
• Close collaboration with Quality, Manufacturing, OpEx, Project Management and Engineering is required for having effective and sustainable

Required Skills:

• Bachelor’s Degree in Science or Engineering, preferably in Engineering, life sciences or related discipline (advanced degree preferred).
• Thorough knowledge of cGMP, FDA and Data Integrity regulations is a must.
• Experience computerized system validations life cycle methodologies, 21 CFR Part 11, and Data Integrity regulations.
• Minimum of six (6) years of computerized/automated system administration within pharmaceutical manufacturing operations with proven skills in management and implementation of computerized systems projects.
• Proven skills in project management and process improvement.
• Ability to impact and influence people/areas within the company to deliver superior business results.
• Excellent communication skills (oral, written and reading) in Spanish and English, including ability to fluidly and effectively communicate IT concepts and business value to non-IT people and business concepts to IT people.
• Ability to work and communicate in a global, culturally diverse, fast-paced matrix team environment. Ability to adapt to changing business needs.
• Strong analytical capabilities and knowledge of related tools and processes.

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.