Empleos en Juana díaz, 00795, puerto rico
Última actualización: hace 12 días
If you’re interested in a career in environmental health, join the Army National Guard as a Water Treatment Specialist.This role is paramount to the health and safety of your fellow Soldiers, and y...Mostrar másÚltima actualización: hace 21 días
This position will provide personal financial services at assigned military installations.Primary responsibilities include the full breadth of personal financial counseling services to military ser...Mostrar másÚltima actualización: hace más de 30 días
For Project Management services WHAT MAKES YOU A FIT : The Technical Part : Bachelor’s Degree in Engineering and at least five (5+) years of experience in Project Mana...Mostrar másÚltima actualización: hace 27 días
The General Service Technician must have a mechanical aptitude and is able to perform basic automotive services including mounting and balancing tires, tire repairs, oil changes, vehicle inspection...Mostrar másÚltima actualización: hace más de 30 días
Supervises all the Logistics Operational activities and the associates.Executing disposition of non-conformance material.
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LL01-031825 Validation Specialist - Medical Devices (Dry & Wet Line Platforms)
Validation & Engineering Group, IncJuana Diaz, 075 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 followin...Mostrar másÚltima actualización: hace 18 días
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LL01-031825 Validation Specialist - Medical Devices (Dry & Wet Line Platforms)
Validation & Engineering Group00795, PR, US 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 ...Mostrar másÚltima actualización: hace 17 días
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Subway - 21686-0 is hiring : Sandwich Artist in 00795
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AutoZoneJuana Diaz, Puerto Rico, United States AutoZone's Part-Time Retail Sales Associates drive sales through superior customer service by exceeding customer expectations and providing a WOW! Customer Service experience.While assisting custom...Mostrar másÚltima actualización: hace más de 30 días
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LL01-031825 Validation Specialist - Medical Devices (Dry & Wet Line Platforms)
Validation & Engineering Group, IncJuana Diaz, 075Hace 18 días
Descripción del trabajoCreate and maintain detailed validation documentation, SOPs (Standard Operating Procedures), and reports. Ensure compliance with FDA, ISO, and company quality management systems. Support CAPA (Corrective and Preventive Actions) investigations related to equipment validation. Conduct requalification and periodic reviews of validated equipment. Analyze data from validation runs, temperature mapping, pressure testing, and process control assessments. Recommend process improvements to enhance efficiency, product quality, and equipment reliability. Work with Engineering, Quality Assurance, Manufacturing, and Maintenance teams to troubleshoot and optimize equipment performance. Provide training and technical support for operators and maintenance personnel on validated processes. Identify root causes of process deviations and failures and implement corrective actions. Evaluate and validate changes in equipment, software, and process parameters. Assist in risk assessments (FMEA, HACCP, etc.) for new and existing equipment. Bachelor’s degree in Engineering, Life Sciences, or a related field. 3+ years of experience in validation, equipment qualification, or quality assurance within the pharmaceutical, biotech, or manufacturing industry. Strong knowledge of cGMP, FDA, ISO 13485, and GAMP 5 guidelines. Experience with thermal validation, process validation, and equipment calibration. Proficiency in data analysis, validation software, and technical writing. Strong problem-solving, organizational, and communication skills.
Department : 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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