Validation Specialist
- Humacao, PR
- Permanente
- Tiempo completo
*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.*Duties*
- Develop and execute *IQ/OQ/PQ protocols* for small steam systems, including autoclaves and SIP (Steam-in-Place) equipment.
- Perform *thermal mapping*, *biological indicator testing*, and *cycle development* for steam sterilization processes.
- 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.
- Support audits and inspections by providing validation documentation and technical expertise.
- 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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