Medical Devices Technician

mAbxience; Madrid; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A growing pharmaceutical company in León, Spain, is seeking a Medical Devices Technician to manage the development and manufacturing of medical devices, including prefilled syringes and autoinjectors. The ideal candidate will have over 5 years of experience in relevant operations and possess strong project management skills. Fluent English is required, with Spanish as a bonus. The role involves ensuring compliance, collaborating on documentation, and supporting regulatory submissions.

Servicios

Permanent contract

Life and accident insurance

Free company canteen

Free online training platform

Free online library

Well-being platform

Formación

• 5+ years of experience in Operations, R&D, MSAT in medical devices development.
• Fluent in English; Spanish knowledge is a plus.

Responsabilidades

• Search technologies and suppliers for medical devices.
• Generate medical devices Design History File (DHF).
• Support regulatory submission process.
• Lead evaluation of process improvements.

Conocimientos

Project management

GMP environment

DHF generation

Regulatory filling (ICH, EMA, FDA)

Tech transfer

Process validation

Educación

University degree in biotechnology, biochemistry, or chemical engineering

Descripción del empleo

Global responsibilities

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.

Specific responsibilities

• Search and selection of new technologies, suppliers and CDMOs for the development and assembly of medical devices.
• Collaborate in generation of medical devices Design History File (DHF) and related documentation.
• Authoring of tech transfer protocols and reports for medical device manufacturing in selected CDMO.
• Scientific support during medical device development, assembly process tech transfer and validation. Deviation root cause and impact assessment, as well as CAPAs.
• Coordination of medical device assembly process implementation and validation at CDMO.
• Generation of risk assessments, process description, bill of materials, manufacturing procedures and sampling plans compliant with regulatory standards and guidelines.
• Support of regulatory submission process, including SME input and / or revision of relevant dossier sections and participation in regulatory agency interactions.
• Lead the evaluation and implementation of process improvements and scale-ups. Support in regulatory variation procedures.

Education

University degree oriented to biotechnology, biochemistry, chemical engineering or the like.

Languages

Fluent English. Knowledge of other languages (mainly Spanish) will be an asset.

Experience

≥5 years of experience in Operations, R&D, MSAT in development and manufacturing of medical devices, mainly prefilled syringes (PFS) coupled with needle safety devices (NSD) and autoinjectors (AI).

Travel

Open to travel.

Personal skills

• Experience in project management and scale up to industrial manufacturing, work in GMP environment, DHF generation and regulatory filling (ICH, EMA and FDA requirements), tech transfer, process validation.

Benefits

• Permanent contract to join a growing pharmaceutical company.
• Life and accident insurance.
• Free company canteen.
• Free online training platform.
• Free online library.
• Social, physical and emotional well-being platform.

Equal opportunity statement

mAbxience is committed to equal opportunities. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.