Principal Engineer, Digital Regulatory Assurance (Life Sciences)
AbbVie
Principal Quality Engineer providing regulatory assurance and quality oversight for IT applications and technology solutions in a regulated life sciences environment. Serves as senior subject matter expert in Software Lifecycle processes, Computer Software Assurance, infrastructure qualification, and compliance. Leads modernization of quality processes through automation, data-driven monitoring, and AI-enabled solutions.
Responsibilities
- Provide quality and regulatory oversight for GxP-relevant applications and infrastructure throughout Software Lifecycle
- Lead compliance monitoring activities including validation assessments, audit trail reviews, and health reporting
- Partner with business and technology teams to embed quality and validation requirements into design and deployment
- Drive audit and inspection readiness efforts including preparation, evidence reviews, and remediation planning
- Manage pipeline of automation and AI opportunities to improve quality and compliance outcomes
Requirements
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field with 7 years' experience; or Master's with 6 years; or PhD with 2 years
- Strong experience in process optimization, AI-enabled solutions, audit-readiness, and CAPAs
- Experience supporting DevOps tools and pipeline technologies
- Demonstrated success supporting regulatory audits and implementing quality monitoring solutions
- Expert knowledge of GxP regulations and Computer Software Assurance principles
- Project management, analytical, and technical documentation skills with coaching ability
- Knowledge of digital transformation in quality and contemporary validation practices
Vacancy posted 24 days ago
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