BTS Senior Engineer, Technology I
Core
Enables the full lifecycle of AbbVie's Digitalization of Software Life Cycle by bridging regulation with technology functions for IT governance using modern tooling.
Role type
Senior IC Quality and Compliance Engineer (Regulatory Technology)
Builds
IT governance frameworks, automated control evidence collection, and digital traceability records for regulated systems.
Domain
Pharmaceutical / Medical Device / Regulated Industry
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
IT controls design assurance, CI/CD pipeline automation, regulatory requirement translation, DevOps workflow embedding, digital traceability management, data integrity controls (ALCOA+), audit readiness coordination, stakeholder communication, risk-based approach, GAMP principles
Preferred skills
AI system governance in regulated contexts, Validation 4.0 principles
Technologies
GitHub, Jira, JFrog Artifactory, qTest, ServiceNow CMDB, Azure DevOps, AWS CodePipeline
Responsibilities
Design, implement, maintain, and continuously improve SLC framework across technology systems and platforms; Identify opportunities to automate the collection, validation, and reporting of IT control evidence within CI/CD pipelines; Apply AI tooling to enhance control monitoring, trend analysis, and anomaly detection; Translate between governance and regulatory requirements and the engineering teams responsible for tool configuration and pipeline design; Work directly with teams operating Jira, GitHub, JFrog, qTest, ServiceNow, and related platforms to embed controls at the source; Own digital traceability records linking requirements, controls, system design elements, and verification evidence; Apply ALCOA+ principles and data lifecycle controls across all governed systems; Lead evidence preparation and coordinate remediation for audit and inspection readiness; Surface interdependencies, communicate control status, and translate technical complexity into compliance-relevant language for leadership and governance audiences; Support Validation 4.0 principles including quality by design, data integrity by design, and integrated environments
Seniority
Senior, hands-on IC