Engineer, IT Compliance
About The Position
The 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 position partners with Quality, Business Owners, and Technical Owners to create and manage Quality Systems deliverables throughout the lifecycle of electronic systems and applications, helping ensure regulatory and procedural compliance and support 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 to enter cell therapy manufacturing and testing areas in accordance with company procedures.
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.
- Ability to don appropriate gowning for entry into cell therapy manufacturing and testing areas.
- Ability to lift up to 25 pounds and to sit and stand for extended periods.
Nice To Haves
- Familiarity with computerized systems such as MES, ERP, LIMS, Validation Lifecycle or Testing Software, QMS, and Learning Management Systems.
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 Quality Systems records such as 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 affect 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, subject to plan terms and eligibility.
- Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
- For eligible non-exempt employees, RayzeBio employees, and employees in Puerto Rico: 160 hours of annual paid vacation for new hires, subject to manager approval.
- 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, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves 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.
- Eligible employees may be offered discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
