Sr. Engineer, IT Compliance
About The Position
The Sr. Engineer, IT Compliance works cross-functionally to lead compliance-related activities for GxP electronic systems and applications. The role is primarily an individual contributor, though it may periodically manage supporting contract resources. The Engineer 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. Work takes place in a normal office environment or remotely, as well as in cell therapy manufacturing areas, server rooms, data closets, and warehouses. Appropriate gowning is required when entering cell therapy manufacturing and testing areas, in accordance with company procedures. The role also involves lifting up to 25 pounds and sitting and standing for extended periods.
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 related to 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 record documentation and metrics reporting.
- Familiarity with computerized systems including MES, ERP, LIMS, Validation Lifecycle or Testing Software, QMS, and Learning Management Systems.
- Ability to don appropriate gowning for entry into cell therapy manufacturing and testing areas.
- 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 applicable procedural requirements.
- Perform or lead investigations and root cause analyses for Quality Event deviations related to IT systems.
- Author or contribute 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 impacting 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.
- Perform other job-related duties as requested by management.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
- Flexible Time Off without a set accrual limit 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.
- Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.
- Potential eligibility for discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
