Digital Quality Engineer

AbbVie•Tempe, AZ

3d•$65,500 - $125,500

About The Position

Own the lifecycle management, validation, and sustained operation of digital quality systems and related capabilities. Serve as the Quality subject-matter expert and system owner for digital quality technologies, ensuring solutions are compliant, fit for purpose, inspection-ready, and aligned with cGMP, data integrity, and electronic records/electronic signatures requirements. Partner with Quality, Manufacturing, IT, Engineering, Validation, and other stakeholders to define, configure, test, deploy, and sustain compliant digital solutions. Support validation activities, system changes, investigations, training, continuous improvement, and inspection readiness.

Requirements

Bachelor’s degree in engineering, computer science, life sciences, or a related technical discipline.
5+ years of relevant experience in pharmaceutical, biotechnology, or other regulated manufacturing environments, including Quality, Manufacturing, digital systems, or validation.
Excellent written and verbal communication skills, with the ability to develop clear procedures, training, and inspection-ready documentation.
Ability to work independently, prioritize effectively in a dynamic project environment, and influence stakeholders without direct authority.

Nice To Haves

Advanced degree preferred.
Experience with quality management systems, electronic records systems, manufacturing or laboratory systems, or comparable GxP digital platforms strongly preferred.
Experience with software or computer system validation, including risk-based validation, requirements, testing, traceability, and validation documentation, preferred.

Responsibilities

Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle management, and operational support for quality-related capabilities.
Act as the Quality system subject-matter expert, translating business, cGMP, data integrity, and electronic records/electronic signatures requirements into clear system requirements and operational controls.
Partner with Quality, Manufacturing, IT, Engineering, Validation, and other stakeholders to define, configure, test, deploy, and sustain compliant digital solutions.
Own or coordinate Quality input to software and computer system validation activities, including risk assessments, requirements, test strategy, test execution, traceability, defect resolution, and validation deliverables, as applicable.
Ensure systems and associated processes support accurate, complete, consistent, contemporaneous, and attributable electronic data and records throughout the data lifecycle.
Lead Quality review and approval of system changes, releases, access controls, and periodic assessments through established change-control and quality-system processes.
Support investigation and resolution of system-related deviations, incidents, data-integrity events, and CAPAs; assess product-quality and compliance impact and drive timely, effective actions.
Develop and maintain procedures, work instructions, training materials, and role-based training to promote compliant and effective use of digital quality systems.
Monitor system performance, user feedback, and emerging compliance needs; identify and implement continuous improvements in partnership with functional stakeholders.
Maintain inspection readiness by providing system expertise, validation evidence, traceability, and clear responses to internal audits, regulatory inspections, and health-authority inquiries.