Sr. Engineer, IT Compliance

• Manage department (IT) metrics reporting linked to regulatory compliance and Quality Events, including Deviations, CAPAs, Change Requests, Training, and completion of applicable procedural requirements
• Perform / lead investigations and root cause analyses for Quality Event deviations related to IT systems
• Author / contribute content, review and approve applicable Quality Systems records, including Deviations, CAPAs, Change Requests, SOPs, and others as needed
• Partner with Quality, and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to IT
• Perform periodic reviews of applicable SOPs
• Participate in governance boards, acting as the IT representative for regulatory and procedural compliance
• Support regulatory inspections as a subject matter expert (SME) as needed
• Manage supporting contract resources as needed
• Assist with site integration and enterprise harmonization activities as applicable

Working Conditions:

• Work will be performed in a normal office environment (or remotely) as well as cell therapy manufacturing areas, server rooms, data closets and warehouses.
• Must be able to don appropriate gowning for entering cell therapy manufacturing and testing areas in accordance with company procedures.
• Normal office temperatures and lighting conditions will apply. Must be able to lift up to 25 pounds. Must be able to sit for extended periods. Must be able to stand for extended periods.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management., Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. (https://careers.bms.com/life-at-bms/ways-of-working/)

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

Candidate Rights

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

Bachelor’s degree in a life sciences, engineering, or technology discipline,

or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience., * 2+ years of direct experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs) related activities, with a demonstrated understanding of electronic records / signatures and application of the ALCOA+ principles of data integrity

• Strong knowledge of global Health Authority regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures
• Strong knowledge of Quality Systems records documentation and metrics reporting

Familiar with an array of computerized systems: MES, ERP, LIMS, Validation Lifecycle / Testing Software, QMS, Learning Management System

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year’s Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.