Digital Quality Engineer
AbbVie · Tempe, AZ
- Level
- Engineer
- Team
- Quality
- Degree
- Preferred
- Experience asked
- 5+ years
- Industry
- Pharma & life sciences
- Posted
- 2 days ago
The role in 30 seconds
An engineer-level quality role at AbbVie (pharma & life sciences) in Tempe, AZ. Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle management, and operational support for quality-related capabilities.
- They ask for
- 5+ years · degree preferred
- Tools it names
- Validation (IQ/OQ/PQ), Internal audits
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- 1
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- 2
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About the role
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.
- ✓Bachelor’s degree in engineering, computer science, life sciences, or a related technical discipline; advanced degree preferred.
- ✓5+ years of relevant experience in pharmaceutical, biotechnology, or other regulated manufacturing environments, including Quality, Manufacturing, digital systems, or validation.
- ✓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; ability to be accountable for validation activities as needed.
- ✓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.
Show full description ↓Show less ↑
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.