MSAT Medical Devices Injectables Technician

JR Spain; León; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

Una empresa especializada en el desarrollo y fabricación de medicamentos biosimilares busca un técnico de dispositivos médicos en León. La posición implica la gestión de la implementación de procesos para dispositivos médicos, con un enfoque en la colaboración con equipos de desarrollo y proveedores externos. Se requiere un título universitario relacionado y experiencia significativa en el área. Se ofrece un contrato permanente con beneficios como seguro de vida y capacitación en línea.

Servicios

Seguro de vida y accidentes

Comedor gratuito

Capacitación en línea

Formación

• Experiencia de al menos 5 años en Operaciones, I+D o MSAT relacionado con dispositivos médicos.
• Fluidez en inglés y conocimiento de español es un plus.
• Disposición para viajar.

Responsabilidades

• Coordinar la implementación de procesos de fabricación de dispositivos médicos para nuevos moléculas.
• Asistir en la elaboración del dossier de diseño y documentación relacionada.
• Apoyar en las presentaciones regulatorias.

Conocimientos

Gestión de proyectos

Conocimientos en entorno GMP

Validación de procesos

Educación

Grado universitario en biotecnología, bioquímica o ingeniería química

Descripción del empleo

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Client:

mAbxience

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Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

395793546991160524832460

Job Views:

1

Posted:

23.07.2025

Expiry Date:

06.09.2025

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Job Description:

From Mabxience, a company specialized in the development and manufacture of biosimilar medicines, we are hiring a MSAT medical devices technician for our plant in León.

Global responsibilities

The medical device specialist will serve as a drug-device combination expert, including planning and coordinating the implementation of medical devices manufacturing processes for new molecules under development in external CDMOs. Collaborate with mAbxience development team and third-party companies during device development stages and regulatory submissions.

Specific responsibilities

• Search and select new technologies, suppliers, and CDMOs for medical device development and assembly.
• Assist in generating the medical devices Design History File (DHF) and related documentation.
• Author tech transfer protocols and reports for medical device manufacturing in selected CDMOs.
• Provide scientific support during device development, assembly process transfer, and validation. Conduct deviation root cause analysis, impact assessment, and CAPAs.
• Coordinate medical device assembly process implementation and validation at CDMOs.
• Generate risk assessments, process descriptions, bills of materials, manufacturing procedures, and sampling plans compliant with regulatory standards.
• Support regulatory submissions, including SME input, dossier revisions, and agency interactions.
• Lead evaluation and implementation of process improvements and scale-ups. Support regulatory variation procedures.

Requirements and personal skills

• Education: University degree in biotechnology, biochemistry, chemical engineering, or related fields.
• Languages: Fluent English required. Knowledge of Spanish is a plus.
• Experience: ≥5 years in Operations, R&D, or MSAT related to medical devices, especially prefilled syringes, needle safety devices, and autoinjectors.
• Travel: Willing to travel.
• Personal skills: Project management, scale-up experience, GMP environment knowledge, DHF generation, regulatory filings (ICH, EMA, FDA), tech transfer, and process validation expertise.

We offer a permanent contract with benefits including life and accident insurance, a free canteen, online training and library, and well-being platforms.

mAbxience is committed to equal opportunity employment and does not discriminate based on ethnicity, religion, age, sex, nationality, marital status, sexual orientation, gender identity, disability, or other personal circumstances.