MSAT Medical Devices Injectables Technician

JR Spain; España; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A biopharmaceutical company, mAbxience, seeks an MSAT medical devices technician for their León plant. The role involves expertise in medical device manufacturing processes, project management, and regulatory compliance. Candidates should have a degree in a related field and significant experience in operations or R&D for medical devices, with competitive salary and benefits offered.

Servicios

Life and accident insurance

Free canteen

Online training and library access

Well-being platforms

Formación

• Fluent in English; Spanish or other languages are a plus.
• A minimum of 5 years experience in Operations, R&D, or MSAT related to medical device development.
• Willingness to travel is required.

Responsabilidades

• Act as drug device combination expert and coordinate manufacturing processes.
• Assist in the creation of Design History Files (DHF) and related documentation.
• Lead process improvements and support regulatory submissions.

Conocimientos

Project management

GMP environment experience

Regulatory filings

Tech transfer

Process validation

Educación

University degree in biotechnology, biochemistry, chemical engineering

Descripción del empleo

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Client:

mAbxience

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

883587640662268313632460

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 incorporating a MSAT medical devices technician for our plant in León.

Global responsibilities

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

Specific responsibilities

• Search and selection of new technologies, suppliers, and CDMOs for the development and assembly of medical devices.
• Assist in the creation of medical devices Design History Files (DHF) and related documentation.
• Author protocols and reports for tech transfer and manufacturing of medical devices in selected CDMOs.
• Provide scientific support during development, assembly process tech transfer, and validation. Address deviations, root causes, impact assessments, and CAPAs.
• Coordinate medical device assembly process implementation and validation at CDMO.
• Create risk assessments, process descriptions, BOMs, procedures, and sampling plans aligned with regulatory standards.
• Support regulatory submissions, including SME input, dossier revisions, and agency interactions.
• Lead process improvements, scale-ups, and support regulatory variation procedures.

Requirements and personal skills

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

We offer a permanent contract with benefits including life and accident insurance, 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.