Fusion Consulting logo
Fusion Consulting

Shaping the Future of Life Science Consulting Worldwide

Subject Matter Expert – MES

Product MarketingProduct MarketingFull TimeRemoteSeniorTeam 501-1,000Since 2012H1B SponsorCompany SiteLinkedIn

Location

Spain

Posted

1 day ago

Salary

0

Seniority

Senior

SpanishEnglish

Job Description

Subject Matter Expert – MES

Fusion Consulting

• Actuar como experto MES para procesos de ejecución de fabricación dentro de entornos farmacéuticos. • Participar en la definición y revisión de Process Requirement Specifications (PRS) y diseños funcionales. • Asesorar en el diseño de recetas, Electronic Batch Records (EBR) y procesos de fabricación. • Impulsar iniciativas de estandarización y armonización mediante plantillas, librerías y mejores prácticas reutilizables. • Colaborar con equipos de Producción, Calidad, Validación e IT para alinear los requisitos de negocio con las capacidades del sistema MES. • Participar en el diseño y revisión de integraciones entre MES y otros sistemas corporativos o de planta. • Apoyar la definición de arquitecturas funcionales y flujos de datos relacionados con la ejecución de fabricación. • Dar soporte a actividades de testing, validación, despliegue y hypercare. • Facilitar la transferencia de conocimiento y actuar como mentor para otros miembros del equipo. • Contribuir a iniciativas de mejora continua y gobierno de soluciones MES.

Job Requirements

  • Experiencia demostrable trabajando con soluciones MES dentro de la industria farmacéutica o Life Sciences.
  • Participación en proyectos de implantación, despliegue, soporte o evolución de sistemas MES.
  • Conocimiento sólido de procesos de fabricación farmacéutica, Electronic Batch Records (EBR) y operaciones de planta.
  • Experiencia trabajando con integraciones entre MES y otros sistemas corporativos o industriales.
  • Buen conocimiento de entornos regulados y procesos de validación.
  • Experiencia con plataformas MES como PAS-X, Opcenter, Syncade, PharmaSuite, Camstar, POMSnet o soluciones similares.
  • Experiencia en integraciones con SAP, LIMS, sistemas de automatización, historiadores de datos u otros sistemas de fabricación.
  • Conocimiento de GxP, GAMP 5, CSV/CSA y principios de Data Integrity.
  • Capacidad para liderar workshops y actuar como referente funcional y técnico en temas MES.
  • Excelentes habilidades de comunicación y gestión de stakeholders.
  • Experiencia facilitando transferencia de conocimiento y colaborando con equipos multidisciplinares.
  • Capacidad para trabajar en entornos internacionales y proyectos globales.
  • Español e inglés fluido (oral y escrito).

Benefits

  • Workflex: Disfruta de hasta 25 días al año trabajando desde el lugar del mundo que prefieras.
  • Flexibilidad y conciliación: Fomentamos un equilibrio saludable entre la vida profesional y personal, con políticas flexibles que favorecen el bienestar de nuestros empleados.
  • Presupuesto anual de formación: Dispondrás de 1.500 CHF al año para invertir en tu desarrollo profesional y adquirir nuevas competencias.
  • Aprendizaje continuo: Forma parte de una organización que impulsa el crecimiento constante y la adquisición de nuevas habilidades.
  • Movilidad internacional: Apoyo en asignaciones internacionales, procesos de visado, permisos de trabajo y reubicación cuando sea necesario.
  • Unity Scheme: Programa de reconocimiento y fidelización para empleados a partir de los 3 años de antigüedad.
  • Programa de referidos: Obtén recompensas por recomendar profesionales que se incorporen con éxito a la compañía.
  • Beneficios locales: Acceso a beneficios específicos adaptados a cada país.
  • People First: Trabaja junto a algunos de los mejores profesionales del sector Life Sciences en un entorno colaborativo, dinámico e internacional.
  • Entorno global: Forma parte de una organización verdaderamente global, donde la diversidad, el trabajo en equipo y el apoyo mutuo son la base de nuestro éxito.

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