Quality Engineer - Software & Process Validation
Core
Ensuring computerized systems, manufacturing processes, and equipment consistently perform as intended and comply with regulatory and quality requirements.
Role type
Quality Engineer (Software & Process Validation)
Builds
Validated computerized systems, manufacturing processes, and equipment for regulated industries
Domain
Life Sciences / Healthcare / Manufacturing
Required skills
Computerized System Validation (CSV), Risk Assessment, Data Integrity, GxP/cGMP compliance, Technical Writing, Change Control, CAPA management, Audit Support, IQ/OQ/PQ execution, Traceability Matrix creation
Preferred skills
eQMS validation, ERP/Cloud/SaaS validation, Cleaning Validation, Technology Transfer, ISO 9001 knowledge, FDA 21 CFR Parts 11/210/211 knowledge, Multilingual communication (Spanish/Portuguese)
Technologies
GxP systems, ERP, Cloud/SaaS applications, eQMS, Laboratory Information Management Systems (LIMS)
Responsibilities
Lead software validation for new systems and changes; Support audits, inspections, and quality investigations; Evaluate data integrity controls and security; Support process and equipment validation (IQ/OQ/PQ); Apply change control and risk-management requirements; Develop and execute validation plans.
Seniority
Mid-level, hands-on IC