Validation And Csv Engineer

hace 2 días


San Juan, San Juan, Puerto Rico Lumiere Systems A tiempo completo

Job Description: Minimum of 5 Yr exp leading the validation of a major capital automation projects.
1.
Validation and Compliance Knowledge GxP (Good Practice) Guidelines: Familiarity with GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
FDA 21 CFR Part 11: Understanding of the regulatory requirements related to electronic records and signatures.
ISO Standards: Familiarity with ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security).
Validation Lifecycle Management: Knowledge of the entire lifecycle from planning, execution, and reporting, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
2.
Computer System Validation (CSV) Expertise CSV Methodologies: Strong understanding of CSV processes, including risk-based approach, qualification testing, validation protocols, and traceability matrix development.
System Integration & Interface Testing: Skills in validating interfaces between different systems, including ensuring data integrity during integration.
Software Testing: Experience with software test methodologies (e.g., functional, performance, stress testing).
Documentation & Reporting: Creating and maintaining validation documentation such as protocols, reports, and deviations.
Proficiency in technical writing is key.
3.
SCADA, SAP 4.
Nice to have: Work experience in the medical device industry Computer System Validation (CSV), Validation, IQ, OQ, PQ, FAT, SAT



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