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DescripciónDescription
Validation Specialist with hands-on experience in small steam sterilization systems (e.g., autoclaves, SIP systems). This role is responsible for ensuring that equipment, utilities, and processes meet regulatory and operational standards through the execution of validation protocols and documentation.
Key Responsibilities:
Develop and execute IQ/OQ/PQ protocols for small steam systems, including autoclaves and SIP (Steam-in-Place) equipment.
Analyze validation data and prepare comprehensive reports in compliance with GMP, FDA, and ISO standards.
Collaborate with cross-functional teams (QA, Engineering, Manufacturing) to support validation activities and resolve discrepancies.
Participate in deviation investigations, CAPAs, and change control assessments related to validated systems.
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Requisitos Requirements
Bachelor’s degree in Engineering, Life Sciences, or a related field.
2–5 years of experience in validation, with a focus on steam sterilization systems.
Excellent technical writing and documentation skills.
Bilingual (Spanish/English)
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