Digital Quality Engineer
Core
Own the lifecycle management, validation, and sustained operation of digital quality systems to ensure compliance with cGMP, data integrity, and electronic records/signatures requirements in regulated environments.
Role type
Senior IC Quality Engineer (Digital Systems & Validation)
Builds
Compliant digital quality systems, validation documentation, and operational controls for pharmaceutical/biotech manufacturing.
Domain
Pharmaceutical/Biotechnology / Quality Assurance & Computer System Validation
Required skills
cGMP compliance, data integrity, electronic records/electronic signatures, computer system validation, risk assessment, change control, CAPA management, stakeholder partnership, procedure development, inspection readiness
Preferred skills
GxP digital platforms, manufacturing/laboratory systems, advanced degree, 5+ years in regulated manufacturing
Technologies
Electronic Records Systems, Manufacturing/Laboratory Systems, GxP Digital Platforms
Responsibilities
Lead implementation, enhancement, and operational support of digital quality systems; translate regulatory requirements into system controls; partner with IT/Engineering/Manufacturing to define, configure, test, and deploy compliant solutions; own Quality input for software validation activities (risk assessments, test strategies, traceability); ensure accurate and attributable electronic data throughout the lifecycle; lead review and approval of system changes and access controls; support investigation of deviations and data-integrity events; develop training materials and procedures; monitor system performance and drive continuous improvement; maintain inspection readiness for audits and regulatory inquiries
Seniority
Senior, hands-on IC