Tecnico-Jobs in Spanien

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mAbxience

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395793546991160524832460

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23.07.2025

06.09.2025

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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.