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Computer System Validation (CSV) Engineer / Specialist

FiDelis SolutionsGurabo, Gurabo
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Overview

Schedule
Full-time
Education
Engineering (PE)
Career level
Senior-level
Remote
On-site
Benefits
Health Insurance
Paid Vacation
Paid Sick Leave

Job Description

El Ingeniero / Especialista en Validación de Sistemas Computarizados (CSV) será responsable de apoyar la validación y gestión del ciclo de vida de sistemas computarizados dentro de un entorno regulado GxP. Esta posición garantiza que los sistemas cumplan con los requisitos regulatorios, de integridad de datos, calidad y cumplimiento durante todo su ciclo de vida.

Responsabilidades Clave

  • Desarrollar y ejecutar documentación de CSV y protocolos de validación.
  • Apoyar la implementación, actualización, modificación y retiro de sistemas.
  • Aplicar principios de GAMP 5, GxP/cGMP, FDA 21 CFR Parte 11, Anexo 11 de la UE y ALCOA+.
  • Realizar evaluaciones de riesgo, pruebas de validación, evaluaciones de impacto y pruebas de regresión.
  • Brindar apoyo en desviaciones, CAPAs, investigaciones, auditorías e inspecciones regulatorias.
  • Colaborar con los equipos de TI, Ingeniería, Automatización, Aseguramiento de Calidad, Manufactura, Laboratorio y proveedores externos.
  • Trabajar con sistemas como MES, SCADA, HMI, PLC, DCS, BMS/EMS, LIMS, CDS, QMS, ERP y bases de datos de manufactura.

Requirements

  • Bachillerato o Licenciatura en Ingeniería, Ciencias de la Computación, Tecnologías de la Información, Ciencias de la Vida o un campo relacionado.
  • Experiencia trabajando con sistemas computarizados en industrias farmacéuticas, biotecnológicas, de dispositivos médicos u otras industrias reguladas.
  • Conocimiento de CSV, Ciclo de Vida del Desarrollo de Software (SDLC), GxP/cGMP, FDA 21 CFR Parte 11, GAMP 5 y ALCOA+.
  • Experiencia en el desarrollo de protocolos de validación y documentación técnica.
  • Excelentes habilidades de comunicación y redacción técnica.
  • Capacidad para trabajar eficazmente con equipos multidisciplinarios.
  • Deseable: Experiencia con Kneat, Rockwell/Allen-Bradley, Siemens, Schneider, Ignition, AVEVA/Wonderware, DeltaV, PI y plataformas de validación como ValGenesis o Veeva.

    • Benefits

  • Plan Médico
  • Plan de Retiro 401(k)
  • 15 días de vacaciones
  • 12 días por enfermedad
  • Días feriados pagados
  • Bono de Navidad
  • Oportunidades de crecimiento profesional

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    FAQs About Computer System Validation (CSV) Engineer / Specialist Jobs at FiDelis Solutions

    What is the work location for this position at FiDelis Solutions?
    This job at FiDelis Solutions is located in Gurabo, Gurabo, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
    What pay range can candidates expect for this role at FiDelis Solutions?
    Employer has not shared pay details for this role.
    What employment applies to this position at FiDelis Solutions?
    FiDelis Solutions lists this role as a Full-time position.
    What experience level is required for this role at FiDelis Solutions?
    FiDelis Solutions is looking for a candidate with "Senior-level" experience level.
    What education level is required for this job?
    The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
    What benefits are offered by FiDelis Solutions for this role?
    FiDelis Solutions offers following benefits: Health Insurance, Paid Vacation, Paid Sick Leave, Career Development, and 401k Matching/Retirement Savings for this position. Actual benefits may vary depending on the employer's policies and employment terms.
    What is the process to apply for this position at FiDelis Solutions?
    You can apply for this role at FiDelis Solutions either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.