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We are seeking a skilled Validation Engineer to join our team. The ideal candidate will be responsible for developing and implementing validation protocols and ensuring compliance with FDA regulations and internal quality standards.
Job Responsibility:
Prepare Validation Master Plans and author validation protocols (IQ, OQ, PQ) in accordance with FDA regulations
Execute validation activities and manage associated processes, including change controls, CAPA, and deviation records
Monitor and ensure data integrity
compile and analyze data for summary reports and trend analysis
Support regulatory audits and internal self-inspections
Ensure compliance with applicable Standard Operating Procedures (SOPs) and quality requirements
Requirements:
Bachelor’s degree in Science, Technology, Engineering, or related field
Minimum 5 years of experience in validation or a related occupation
Strong understanding of FDA regulations and cGMP requirements
Experience with CAPA systems, deviation handling, and audit readiness is preferred
Excellent analytical, documentation, and communication skills
Nice to have:
Experience with CAPA systems, deviation handling, and audit readiness
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