[LR567] QC Microbiology Technician

Leanbio; Barcelona; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

Leanbio recherche un Technicien de Microbiologie pour rejoindre son équipe QA dans de nouvelles installations à Sant Quirze del Vallès. Le candidat idéal aura une formation avancée en microbiologie et 5 ans d'expérience en contrôle qualité dans un environnement réglementé GMP. Le poste inclut la réalisation d'analyses microbiologiques, la gestion des systèmes qualité et la collaboration interfonctionnelle pour assurer la conformité et la qualité des produits.

Formación

• 5 ans d'expérience en contrôle qualité dans l'industrie pharmaceutique.
• Expertise dans les systèmes d'eau pharmaceutiques et la surveillance en salle blanche.
• Connaissance des principes ALCOA++ et des pratiques de documentation GMP.

Responsabilidades

• Réaliser des analyses microbiologiques des échantillons environnementaux et produits pharmaceutiques.
• Participer aux études de qualité et à la mise en œuvre des CAPA.
• Collaborer avec les équipes QA, production et validation.

Conocimientos

Analyses microbiologiques

Contrôle qualité

Techniques de surveillance environnementale

Educación

Formation avancée en analyse microbiologique

Descripción del empleo

Leanbio is a leading Biopharmaceutical CDMO offering end-to-end services in the field of recombinant proteins, mRNA and pDNA. With over a decade of expertise, we have a proven track record in development and manufacturing of therapeutic molecules such as antibodies, Fab fragments, ADCs, enzymes, complex proteins, mRNA and pDNA.

Leanbio has already worked with over 100 candidates over these years, some already in late clinical stages. Leanbio is expanding its development and manufacturing capabilities with a new GMP site in Barcelona with over 4,000 sqm. and three manufacturing areas: one for mammalian expression systems up to 2000L, another for microbial and yeast up to 1000L, and a third are for mRNA up to 50L.





The new facility includes state-of-the-art development laboratories, oustanding Quality control rooms and warehouse. Leanbio is a global service provider for the development and manufacturing of biologics. Our commitment to excellence is evident in everything we do:

Prioritizing customer satisfaction. Providing cutting-edge end-to-end services. Utilizing state-of-the-art facilities. Offering extensive expertise in biologics.

We are looking for a new person to join the QC team as a Microbiology Technician to work in our brand new facilities in Sant Quirze del Vallès:

MAIN RESPONSIBILITIES:

Perform microbiological analyses of environmental samples, water for injection (WFI), purified water, cleaning validation samples, and pharmaceutical products according to USP, EP, and internal methodologies. Conduct endotoxin testing and bioburden assessments in compliance with regulatory requirements. Support the setup, execution, and routine operation of the environmental monitoring program including surface and air sampling in classified cleanroom areas.



Carry out sampling activities across manufacturing, cleaning processes, and water systems ensuring proper sample collection, handling, and traceability. Maintain inventory and control of microbiological reagents, media, and consumables ensuring availability and proper storage conditions. Collect, document, and report microbiological sample results accurately ensuring full compliance with GMP and ALCOA++ principles. Maintain detailed and contemporaneous records in laboratory notebooks, logbooks, or electronic systems (LIMS). Participate in quality system activities including investigation of OOS/OOT microbiological results, deviation reporting, and support in CAPA implementation. Maintain laboratory equipment calibration and functionality and promptly report any malfunctions or maintenance needs. Follow all biosafety and safety protocols contributing to maintaining a clean,



organized, and compliant microbiology laboratory environment. Collaborate effectively with QA, production, validation, and other cross-functional teams to support microbiological quality assurance and compliance.

REQUIREMENTS:

Advanced training in microbiological laboratory analysis and control with 5 years of proven experience in Quality Control within a GMP-regulated pharmaceutical environment. Practical expertise in microbiological testing of pharmaceutical water systems, including Water for Injection (WFI) and Purified Water, following USP and EP methods. S killed in environmental monitoring of classified cleanroom areas through surface and air sampling techniques. - Familiarity with microbiological methods such as membrane filtration, microbial enumeration bioburden testing.



Strong knowledge of ALCOA++ data integrity principles and GMP documentation practices. Experienced in managing quality systems including Out of Specification (OOS) investigations, deviation reporting, CAPA implementation, and change control. Proactive team player with strong organizational skills and the ability to work independently while ensuring strict compliance with regulatory requirements. Fluent in Spanish with basic to intermediate English communication skills (reading and writing preferred).

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https://www.kitempleo.es/empleo/212198518/lr567-microbiology-technician-barcelona/?utm_source=html