Qc Microbiology Technician

Leanbio S.L.; Sevilla; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading Biopharmaceutical CDMO in Andalucía, Spain, is seeking a Microbiology Technician for their QC team. This role involves performing microbiological analyses, conducting endotoxin testing, and ensuring compliance with GMP standards. The ideal candidate will have advanced training in microbiological analysis and at least 5 years of experience in a GMP pharmaceutical environment, with strong skills in environmental monitoring. Fluency in Spanish is required along with basic English skills.

Formación

• 5 years of proven QC experience in GMP pharmaceutical environment.
• Practical expertise in testing pharmaceutical water systems.
• Strong understanding of GMP documentation practices.

Responsabilidades

• Perform microbiological analyses of environmental samples.
• Conduct endotoxin testing and bioburden assessments.
• Maintain detailed records in laboratory notebooks or electronic systems.

Conocimientos

Microbiological analysis

Environmental monitoring

GMP compliance

Data integrity (ALCOA++)

Team collaboration

Educación

Advanced training in microbiological 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.

We have collaborated with over 100 candidates, some in late clinical stages. Leanbio is expanding with a new GMP site in Barcelona, spanning over 4,000 sqm, featuring three manufacturing areas:

• For mammalian expression systems up to 2000L
• For microbial and yeast up to 1000L
• For mRNA up to 50L

The facility includes state-of-the-art laboratories, quality control rooms, and warehouses. As a global service provider, we prioritize:

• Customer satisfaction
• Cutting-edge end-to-end services
• Utilization of advanced facilities
• 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 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.
• Collect, document, and report microbiological sample results accurately, ensuring full compliance with GMP and ALCOA++ principles.
• Maintain detailed records in laboratory notebooks, logbooks, or electronic systems (LIMS).
• Participate in quality system activities, including investigation of OOS/OOT microbiological results, deviation reporting, and CAPA support.
• Maintain calibration and functionality of laboratory equipment, reporting malfunctions promptly.
• Follow biosafety and safety protocols to maintain a compliant microbiology laboratory environment.
• Collaborate with QA, production, validation, and other teams to support microbiological quality assurance and compliance.

REQUIREMENTS :

• Advanced training in microbiological analysis with 5 years of proven QC experience in a GMP pharmaceutical environment.
• Practical expertise in microbiological testing of pharmaceutical water systems, including WFI and purified water, following USP and EP methods.
• Experience in environmental monitoring of classified cleanrooms through surface and air sampling techniques.
• Knowledge of microbiological methods such as membrane filtration and microbial enumeration bioburden testing.
• Strong understanding of ALCOA++ data integrity principles and GMP documentation practices.
• Experience managing quality systems, including OOS/OOT investigations, deviation reporting, CAPA, and change control.
• Proactive team player with organizational skills and the ability to work independently, ensuring regulatory compliance.
• Fluent in Spanish with basic to intermediate English skills (reading and writing preferred).