Senior Validation Engineer
Found in: beBee S US - 2 weeks ago
Senior Validation Engineer
6-9-month contract role
Location: Costa Rica, Role requires fluency in Spanish & English
Shift: Normally work 1st shift but may require to work other shifts and weekends if the project requires
Job Summary:
This position is responsible for development, execution, & analysis of validation projects to demonstrate facility, utility, equipment, and process consistency and cGMP/QSR compliance. The ideal candidate will have both medical device and pharmaceutical experience. Responsibilities include the generation and execution of IQ/OQ/PQ protocols and summary reports for culture media manufacturing and packaging equipment. The selected candidate will also collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches. Other duties include providing validation project management associated with new or modified facilities; acting as an interface between various functional areas (internal and external) to assure successful integration and completion of validation activities in overall project schedules.
• Responsible for development, execution & analysis of validation projects to demonstrate equipment, utility, and facility cGMP/QSR compliance.
• Author and execute IQ/OQ/PQ Protocols for culture media manufacturing and packaging equipment and facilities.
• Provide technical assistance to change controls/CAPA's, and deviations.
• Update and improve SOPs and work instructions.
• Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure and optimization of validation approaches.
• Generate validation-related reports and project plans associated with quality remediation efforts.
Qualifications:
• A Bachelor's of science degree in Pharmacy, Engineering or Science is required.
• Fluency in written and spoken Spanish & English
• 5+ years of experience in life sciences engineering is required.
• 2+ years of experience in validation is required.
• Experience working in FDA/cGMP compliant environment required.
• Strong collaboration, communication, and presentation skills required.
• Expert-level proficiency with Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
Ingeniero Senior de Validación
Rol de contrato de 6 a 9 meses
Ubicación: Costa Rica, el puesto requiere fluidez en español e inglés.
Turno: normalmente trabaja en el primer turno, pero es posible que deba trabajar en otros turnos y fines de semana si el proyecto lo requiere.
Resumen de trabajo:
Este puesto es responsable del desarrollo, ejecución y análisis de proyectos de validación para demostrar la coherencia de las instalaciones, los servicios públicos, los equipos y los procesos y el cumplimiento de cGMP/QSR. El candidato ideal tendrá experiencia tanto en dispositivos médicos como en productos farmacéuticos. Las responsabilidades incluyen la generación y ejecución de protocolos IQ/OQ/PQ e informes resumidos para equipos de embalaje y fabricación de medios de cultivo. El candidato seleccionado también colaborará con personal técnico y de gestión interno y externo para establecer las prioridades, objetivos, estructura y optimización de los enfoques de validación del proyecto. Otras funciones incluyen proporcionar gestión de proyectos de validación asociados con instalaciones nuevas o modificadas; actuando como una interfaz entre varias áreas funcionales (internas y externas) para asegurar una integración exitosa y la finalización de las actividades de validación en los cronogramas generales del proyecto.
Descripción del trabajo:
• Responsable del desarrollo, ejecución y análisis de proyectos de validación para demostrar el cumplimiento de cGMP/QSR de equipos, servicios e instalaciones.
• Crear y ejecutar protocolos IQ/OQ/PQ para equipos e instalaciones de fabricación y envasado de medios de cultivo.
• Brindar asistencia técnica para cambios de controles/CAPA's y desviaciones.
• Actualizar y mejorar SOP e instrucciones de trabajo.
• Colaborar con personal técnico y de gestión interno y externo para establecer prioridades, objetivos, estructura y optimización de los enfoques de validación del proyecto.
• Generar informes relacionados con la validación y planes de proyecto asociados con los esfuerzos de remediación de calidad.
Calificaciones:
• Se requiere una Licenciatura en Ciencias en Farmacia, Ingeniería o Ciencias.
• Fluidez en español e inglés hablado y escrito
• Se requieren más de 5 años de experiencia en ingeniería de ciencias biológicas.
• Se requieren más de 2 años de experiencia en validación.
• Se requiere experiencia trabajando en un entorno compatible con FDA/cGMP.
• Se requieren fuertes habilidades de colaboración, comunicación y presentación.
• Se requiere dominio de nivel experto con Microsoft Office (Word, Excel, PowerPoint y Outlook).
Company Description We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer. Company Description We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.
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