Medical Equipment Validator

Há 6 dias

Curitiba, Paraná, Brasil beBeeValidation Tempo inteiro R$60.000 - R$85.000
Validation Specialist - Medical Devices (Dry and Wet Line Platforms)

The role of the Validation Specialist involves ensuring that manufacturing equipment within the Dry Line and Wet Line Platforms meets industry regulations. This includes overseeing validation protocols, conducting testing, troubleshooting equipment issues, and ensuring adherence to standards such as cGMP, FDA, ISO, and company quality requirements.

Key Responsibilities:
  • Equipment Validation & Qualification
  • Develop and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for specific equipment.
  • Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
  • Ensure all validation activities comply with 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 and Skills Required:
  • 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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