Engineer, IT Compliance

Bristol Myers Squibb • Bothell, WA

6d

About The Position

The Engineer, IT Compliance works cross-functionally to lead compliance-related activities for GxP electronic systems and applications. Primarily an individual-contributor role, it may periodically manage supporting contract resources. The position partners with Quality, Business Owners, and Technical Owners to create and manage Quality Systems deliverables for electronic systems and applications throughout their lifecycle, ensuring regulatory and procedural compliance and supporting the site’s right to operate.

The role works with IT compliance metrics and Quality Events, performs investigations and root cause analyses, contributes to and approves Quality Systems records, and supports continuous improvement, governance, regulatory inspections, and integration and harmonization activities. Work takes place in an office environment or remotely, as well as cell therapy manufacturing and testing areas, server rooms, data closets, and warehouses. Appropriate gowning is required when entering designated manufacturing and testing areas.

Requirements

• Bachelor's degree in a life sciences, engineering, or technology discipline, or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.
• At least 2 years of direct experience with Quality Systems activities involving Deviations, CAPAs, Change Requests, and SOPs.
• Demonstrated understanding of electronic records and signatures and application of ALCOA+ data integrity principles.
• Strong knowledge of global Health Authority regulations and current industry practices, with experience applying guidelines and regulations related to computerized systems, electronic records, and electronic signatures.
• Strong knowledge of Quality Systems records documentation and metrics reporting.
• Familiarity with computerized systems such as MES, ERP, LIMS, Validation Lifecycle / Testing Software, QMS, and Learning Management Systems.
• Ability to don appropriate gowning for entry into cell therapy manufacturing and testing areas in accordance with company procedures.
• Ability to lift up to 25 pounds and sit and stand for extended periods.

Responsibilities

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

Benefits

• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays each year.
• Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• Depending on eligibility, 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 may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Eligible employees may also be eligible for discretionary cash incentives and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level