344532BR
May 05, 2022
Spain

Job Description

769 million! That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

As validation Expert you'll execute, support and manage sterilization validation activities, manufacturing processes, cleaning procedures and change management activities to meet cGMP requirements on time and in quality, ensuring site validation programs meet expectations global regulatory standards.
Manage deviations associated with validations and make recommendations for their resolution and prevention of recurrence.

Your responsibilities include, but not limited to:

• Write and review protocols and validation reports
• Plan or support the planning of site validations,
preparing and managing compliance with the
Validation Master Plan (VMP)
• Support process validation life-cycle activities by
ensuring a state of control is maintained through
Continuous Process Verification.
• Ensuring that appropriate variables are identified to
monitor and contribute to quality risk management
activities.
• In addition you'll manage activities and projects
autonomously.

• Ejecutar, dar soporte y gestionar actividades de
validación de esterilización, procesos de fabricación,
procedimientos de limpieza y actividades de gestión
de cambios para cumplir con los requisitos de cGMP
a tiempo y en calidad, garantizando que los
programas de validación del site cumplan con las
expectativas regulatorias globales
• Gestionar las desviaciones asociadas con las
validaciones y hacer recomendaciones para su
resolución y prevención de recurrencias.
• Redactar y revisar protocolos e informes de validación
• Planificar o apoyar la planificación de las validaciones
del site preparando y gestionando el cumplimiento del
Validation Master Plan (VMP)
• Respaldar las actividades del ciclo de vida de la
validación del proceso al garantizar que se mantenga
un estado de control a través de la Verificación
Continua de Proceso (OPV).
• Asegurar que se identifiquen las variables apropiadas
para monitorizar y contribuir a las actividades de
gestión de riesgos de calidad
• Gestionar las actividades y proyectos bajo su propia
responsabilidad

What you’ll bring to the role:

Leadership and decision-making ability. Autonomy and capacity for organization and planning the ability to analyze and resolve incidents working in multidisciplinary teams. You'll be action-oriented and curious to continuously improve technical knowledge and optimize processes.


Liderazgo y capacidad de tomar decisiones. Autonomía y capacidad de organización y planificación y la capacidad de análisis y resolución de incidencias trabajando en equipos multidisciplinares. Orientado a la acción con una
curiosidad para mejorar continuamente el conocimiento técnico y optimizar los procesos.


You’ll receive:

Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education: BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.

Languages: Fluent in English, written and spoken (minimum B2) Fluent Spanish, written & spoken

Relevant Experiences:

• 3+ years experience in manufacturing/ manufacturing
science and technology/technical
development/quality.
• Thorough understanding of manufacturing processes
and related process equipment.
• Strong working knowledge of quality systems and
regulatory requirements across multiple health
authorities.

Desirable:

• Highly valuable knowledge and experience in Aseptic
environment and sterilization and decontamination
procedures of facilities

• Systems knowledge: SAP, Trackwise y Agile PLM

Requisitos indispensables:

Educación: Carrera Universitaria en Quimica,
Biología, ingeniería Química

Idiomas: inglés y español fluido. Nivel de inglés
mínimo requerido B2

Experiencia:

• 3+ años en áreas de Produccion, MS&T, desarrollo,
Ingienería y/o Calidad
• Conocimientos de procesos y tecnologías de
fabricación y validaciones en el entorno de la
industria farmacéutica (proceso, limpieza,
esterilización)
• Conocimientos de los sistemas de calidad
farmacéuticos y los requisitos regulatorios de las
autoridades sanitarias


Requisitos valorables:

• Altamente valorable conocimiento y experiencia en
entorno Aséptico y procedimientos de esterilización y
descontaminación de instalaciones
• Experiencia en el uso de sistemas SAP, Trackwise y
Agile PLM
Novartis Technical Operations
NTO SANDOZ TECHOPS
Spain
Barcelona Palafolls
Technical Operations
Full Time
Regular
No
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344532BR

MS&T Validation Expert

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