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LL01-031825 Validation Specialist - Medical Devices (Dry & Wet Line Platforms)
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Validation & Engineering Group, IncJuana Diaz, 075Department : Field - LL Location : Juana Diaz, 075
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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position :
Validation Specialist – Dry & Wet Line Platforms
Job Summary :
The Validation Specialist is responsible for the qualification, validation, and ongoing compliance of manufacturing equipment within the Dry Line and Wet Line Platforms. This includes overseeing validation protocols, conducting testing, troubleshooting equipment issues, and ensuring adherence to industry regulations such as cGMP, FDA, ISO, and company quality standards.
Key Responsibilities :
Equipment Validation & Qualification
- Develop and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for the following equipment :
- Dry Line Platform : Injection Molding Machine, Temperature Control Unit, Filling & Close, Oven, Depetaler.
- Wet Line Platform : Delenser Machine, Extraction and Hydration Machine, HH Machine Module 3, HH Machine Module 4.
- Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Ensure that all validation activities comply with cGMP (Current Good Manufacturing Practices) and regulatory requirements.
Documentation & Compliance
Process & Performance Monitoring
Cross-Functional Collaboration
Troubleshooting & Continuous Improvement
Qualifications & Skills :
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