MSAT DP Technician — Tech Transfer & Process Validation

mAbxience; León; Presencial; EUR 42.000 - 56.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Life and accident insurance

Free company canteen

Free online training platform

Free online library

Well-being platform

Descripción de la vacante

Mabxience is seeking an MSAT DP Technician for the León, Spain plant to support technology transfer, validation and optimization of drug product manufacturing processes in Fill & Finish CMOs.

Responsibilities include collaboration with R&D, development of process validation plans, generation of regulatory documents, and provision of technical support during audits. The role requires at least 2 years in F&F operations and a background in biological or chemical sciences.

Formación

• Education: University studies in biological or chemical sciences.
• Languages: Intermediate to high English; fluency is an asset.

Responsabilidades

• Technology transfer and validation of DP manufacturing processes in Fill & Finish CMOs.
• Technical communication with Fill & Finish CMOs.
• Implementation and optimization of DP manufacturing for GMP batches.
• Development of DP process with R&D incl. FMEA and risk assessment.
• Process validation plan, reports and control strategy definition.
• Generation of DP manufacturing and validation documents for CMO.
• Review of manufacturing campaign data and trend reports.
• Support in audits and regulatory activities regarding DP manufacturing.

Conocimientos

Independent work

Prioritization

Motivation

Adaptability

English proficiency

Educación

Biology or Chemistry degree

Descripción del empleo

Mabxience is seeking an MSAT DP Technician for the León, Spain plant to support technology transfer, validation and optimization of drug product manufacturing processes in Fill & Finish CMOs.

Responsibilities include collaboration with R&D, development of process validation plans, generation of regulatory documents, and provision of technical support during audits. The role requires at least 2 years in F&F operations and a background in biological or chemical sciences.