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Validation Specialist
Validation Specialist with hands-on experience in executing validation and qualification activities across diverse areas, including:
Process
Packaging
Manufacturing
Laboratory
Computer System Validation (CSV)
Software
Facilities and Utilities
Site Acceptance Testing (SAT) & Factory Acceptance Testing (FAT)
Commissioning and Decommissioning of Systems and Equipment
Core Competencies:
Skilled in drafting protocols, technical reports, and validation documentation in alignment with regulatory and industry standards (e.g., FDA, GMP).
Proven ability to collaborate effectively with cross-functional teams—including Engineering, Quality, and Production—to ensure compliance, optimize processes, and support operational readiness.
Requisitos: Requirements: Bachelor Degree in Science, or related field Minimum 5 years of experience in validations within a regulated industry. In-depth knowledge of GMP, FDA, and international standards. Hands-on experience in IQ/OQ/PQ, SAT/FAT, and commissioning. Ability to write clear and precise technical documentation. Excellent communication and teamwork skills. Bilingual (English/Spanish - understand, write and speak). Requiere Mucha Experiencia Requires Expert
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