Engineer, IT Compliance

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 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:

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