Process Validation Specialist (ETO)

Detalles de la oferta

Descripción de la oferta: Bachelor Degree Engineering (Industrial, Chemical, Biomedical), Microbiology, Sciences, or related fields) 4 years of experience in process validation (ETO) Strong understanding of ETO sterilization processes and critical parameters (humidity, temperature, concentration, exposure time). Solid knowledge of microbiology applied to sterilization. Proficiency with statistical analysis tools (Minitab, JMP, etc.). Experience in process validation within regulated environments. Familiarity with quality management systems (QMS). Ability to interpret international standards and regulatory requirements. Process Validation Specialist with experience in ethylene oxide (ETO) sterilization processes comply with applicable regulatory, quality, and industry standards, guaranteeing process effectiveness, reproducibility, and safety for medical or industrial products. Responsibilities: Develop, execute, and document IQ/OQ/PQ validation protocols for ETO sterilization processes. Conduct load configuration studies, gas penetration tests, thermal distribution assessments, and residuals evaluations. Analyze microbiological, physicochemical, and process performance data. Ensure compliance with applicable standards such as ISO 11135, ISO 10993-7, ISO 13485, and FDA/EMA regulations.

Oferta

Tipo de contratación: Tiempo Completo

Tipo de turno: Rotativo

Tipo de salario: A discutir

Información general

Plazas disponibles: Tiempo Completo

Publicado el: 23/Feb/2026

Requisitos de la oferta

Tipo de licencia de conducir: Chofer

Auto requerido: No

Requerimos disponibilidad inmediata: Si

Idiomas: Ingles, Español

Grado mínimo: Bachillerato

Concentración: Ingeniería Biomédica

¿Requiere experiencia previa?: Si

Solicitar Empleo

Process Validation Specialist (ETO)

Detalles de la oferta

Descripción de la oferta: Bachelor Degree Engineering (Industrial, Chemical, Biomedical), Microbiology, Sciences, or related fields) 4 years of experience in process validation (ETO) Strong understanding of ETO sterilization processes and critical parameters (humidity, temperature, concentration, exposure time). Solid knowledge of microbiology applied to sterilization. Proficiency with statistical analysis tools (Minitab, JMP, etc.). Experience in process validation within regulated environments. Familiarity with quality management systems (QMS). Ability to interpret international standards and regulatory requirements. Process Validation Specialist with experience in ethylene oxide (ETO) sterilization processes comply with applicable regulatory, quality, and industry standards, guaranteeing process effectiveness, reproducibility, and safety for medical or industrial products. Responsibilities: Develop, execute, and document IQ/OQ/PQ validation protocols for ETO sterilization processes. Conduct load configuration studies, gas penetration tests, thermal distribution assessments, and residuals evaluations. Analyze microbiological, physicochemical, and process performance data. Ensure compliance with applicable standards such as ISO 11135, ISO 10993-7, ISO 13485, and FDA/EMA regulations.

Oferta

Tipo de contratación: Tiempo Completo

Tipo de turno: Rotativo

Tipo de salario: A discutir

Información general

Plazas disponibles: Tiempo Completo

Publicado el: 23/Feb/2026

Requisitos de la oferta

Tipo de licencia de conducir: Chofer

Auto requerido: No

Requerimos disponibilidad inmediata: Si

Idiomas: Ingles, Español

Grado mínimo: Bachillerato

Concentración: Ingeniería Biomédica

¿Requiere experiencia previa?: Si

Solicitar Empleo

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