Sr. Engineer, IT Compliance

Bristol Myers Squibb; United States; Remote; USD 99,000 - 121,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb seeks an Sr. Engineer, IT Compliance to lead cross-functional compliance activities for GxP electronic systems and applications. This role partners with Quality, Business Owners, and Technical Owners to ensure regulatory compliance throughout system lifecycles, including audits and inspections.

Remote-friendly, emphasis on governance and process improvements. Ideal candidates have 2+ years in Quality Systems-related activities, strong ALCOA+ data integrity understanding, and

Qualifications

• Bachelor’s degree or 5+ years biotech/pharma experience.
• Experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs) and data integrity.
• Knowledge of global Health Authority regulations and GxP systems.

Responsibilities

• Lead compliance activities for GxP electronic systems throughout their lifecycle.
• Collaborate with Quality, Business Owners and Technical Owners for Quality Systems deliverables.
• Manage investigations and root-cause analyses for IT-related deviations.
• Review and approve Quality Systems records (Deviations, CAPAs, Change Requests, SOPs).
• Support regulatory inspections as SME and engage in governance boards.
• Coordinate with contract resources and site integration efforts.

Skills

Quality Systems

ALCOA+ data integrity

Regulatory compliance

GxP electronic systems

SOPs

Root cause analysis

Education

Bachelor’s degree in life sciences/engineering/technology

5+ years biotechnology/pharma experience

Tools

MES

ERP

LIMS

Validation Lifecycle / Testing Software

QMS

Learning Management System

Job description

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.

The Sr. Engineer, IT Compliance works cross-functionally to lead compliance-related activities for GxP electronic systems and applications. This role is primarily an individual contributor but may manage supporting contract resources periodically. The Engineer, IT Compliance will partner with Quality, Business Owners, and Technical Owners to create and manage Quality Systems deliverables for electronic systems and applications throughout their lifecycle to ensure regulatory and procedural compliance, supporting the site’s right to operate.

Key Responsibilities

• 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.

Education

Bachelor’s degree in a life sciences, engineering, or technology discipline, or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.

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

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Bothell - WA - US: $99,480 - $120,551

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

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

How We Work

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.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. 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.

For roles based in Los Angeles County only: 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: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607633 : Sr. Engineer, IT Compliance