Qc Microbiology Technician Etj310 | [HX-001]

Leanbio; Barcelona; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical company in Barcelona is seeking a Microbiology Technician to join their QC team. Responsibilities include performing microbiological analyses, conducting endotoxin testing, and supporting environmental monitoring. The ideal candidate has over 5 years of GMP-regulated pharmaceutical experience and advanced training in microbiological laboratory analysis. Proficiency in Spanish and basic English is preferred.

Formación

• At least 5 years of GMP-regulated pharmaceutical QC experience.
• Practical expertise in testing pharmaceutical water systems.
• Experience in environmental monitoring of cleanroom areas.

Responsabilidades

• Perform microbiological analyses of various samples.
• Conduct endotoxin testing and bioburden assessments.
• Support the environmental monitoring program.

Conocimientos

Microbiological analysis

GMP compliance

Environmental monitoring

Team collaboration

Documentation practices

Educación

Advanced training in microbiological laboratory analysis

Descripción del empleo

Leanbio is a leading Biopharmaceutical CDMO offering end-to-end services in recombinant proteins, mRNA, and pDNA. With over a decade of expertise, we have a proven track record in developing and manufacturing therapeutic molecules such as antibodies, Fab fragments, ADCs, enzymes, complex proteins, mRNA, and pDNA. Leanbio has worked with over 100 candidates, some in late clinical stages. We are expanding our capabilities with a new GMP site in Barcelona, covering over 4,000 sqm, with three manufacturing areas: for mammalian systems up to 2000L, microbial and yeast up to 1000L, and mRNA up to 50L. The facility includes advanced development laboratories, quality control rooms, and a warehouse. Leanbio is a global provider committed to excellence by prioritizing customer satisfaction, offering cutting-edge services, utilizing state-of-the-art facilities, and providing extensive expertise in biologics.

We are seeking a Microbiology Technician to join our QC team at our 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 following USP, EP, and internal methodologies.
• Conduct endotoxin testing and bioburden assessments in compliance with regulatory standards.
• Support 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.
• Accurately document and report microbiological results, ensuring GMP and ALCOA++ compliance.
• Keep detailed records in notebooks, logbooks, or electronic systems (LIMS).
• Participate in quality system activities, including investigations of OOS/OOT results, deviation reporting, and CAPA support.
• Maintain calibration and functionality of laboratory equipment, reporting malfunctions promptly.
• Follow biosafety and safety protocols to ensure a clean, organized, and compliant environment.
• Collaborate with QA, production, validation, and cross-functional teams to support microbiological quality assurance.

Requirements:

• Advanced training in microbiological laboratory analysis with at least 5 years of proven GMP-regulated pharmaceutical QC experience.
• Practical expertise in microbiological testing of pharmaceutical water systems, including WFI and purified water, following USP and EP methods.
• Experience in environmental monitoring of cleanroom areas via surface and air sampling techniques.
• Knowledge of microbiological methods such as membrane filtration and bioburden testing.
• Strong understanding of ALCOA++ principles and GMP documentation practices.
• Experience managing quality systems, including OOS investigations, deviation reporting, CAPA, and change control.
• Proactive team player with excellent organizational skills, capable of working independently while complying with regulations.
• Fluent in Spanish; basic to intermediate English skills preferred.