
Data Validation and Automation Specialist
hace 3 días
At Lumiere Systems, we are seeking an experienced Data Validation and Automation Specialist to lead the validation of major capital automation projects. This role requires a minimum of 5 years' experience in leading validation efforts for large-scale automation projects.
Key Responsibilities:
1. Validation and Compliance Knowledge: The ideal candidate will have strong knowledge of GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
Familiarity with regulatory requirements related to electronic records and signatures, including FDA 21 CFR Part 11, is also essential.
2. Computer System Validation (CSV) Expertise: Strong understanding of CSV processes, including risk-based approach, qualification testing, validation protocols, and traceability matrix development.
Skills in validating interfaces between different systems, ensuring data integrity during integration, are also required.
3. SCADA and SAP Experience
Nice to Have:
Work experience in the medical device industry
Key Qualifications:
Strong technical writing skills and ability to create and maintain validation documentation, such as protocols, reports, and deviations.
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