LL01-031825 Validation Specialist - Medical Devices (Dry & Wet Line Platforms)

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

• Create 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.

Process & Performance Monitoring

• 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.

Cross-Functional Collaboration

• 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.

Troubleshooting & Continuous Improvement

• 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.

Qualifications & Skills:

• 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.

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