Senior Validation and Compliance Professional

hace 2 días


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

We are looking for an Engineering Validation Expert - CSV to join our team at Lumiere Systems. In this role, you will be responsible for leading the validation of major capital automation projects. With a minimum of 5 years' experience in leading validation efforts for large-scale automation projects, you will bring expertise in the following areas:
Key Responsibilities:
1. Validation and Compliance Knowledge: Strong knowledge of GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
2. Computer System Validation (CSV) Expertise: Strong understanding of CSV processes, including risk-based approach, qualification testing, validation protocols, and traceability matrix development.
3. System Integration & Interface Testing: Skills in validating interfaces between different systems, ensuring data integrity during integration.
Nice to Have:
Work experience in the medical device industry.
Key Qualifications:
Proficiency in technical writing and ability to create and maintain validation documentation, such as protocols, reports, and deviations.



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