The function of this position is to provide microbiological support and knowledge to the micro team and to other departments. This position also includes performing microbiological testing as required by following approved methodology to assure that the safety, quality, purity and stability of the products, components and in-process stages are in compliance with approved specifications.
The microbiology team is highly flexible and provides cross functional support. This role allows opportunity to become highly skilled within the team and gain experience in all areas essential to the running of a microbiology department.
This will be a day role Monday to Friday however changes to working hours (including temporary shift working hours) and overtime may be required.
Key responsibilities:
- Provide microbiological support to the Quality Assurance, Qualified Persons, Validation and Manufacturing departments as well as other areas on site.
- Documentation review and batch release review.
- Provide technical guidance and expertise to QC Microbiology Team and external departments. In particular, close contact maintained with the Microbiology, Validation, Manufacturing,
Planning and Quality Assurance.
- Execution of QC-Micro testing (water sampling, water testing, growth promotion, identifications, Sterility testing, Environmental monitoring and plate reading) as required.
QC-Micro Skills:
- Water Sampling and Testing
- Collection and microbiological analysis of water samples.
- Includes Biochemical Oxygen Demand (BOD) testing and particulate analysis.
- Air and Surface Sampling (Environmental Monitoring)
- Air and surface sample collection using settle plates, contact plates, swabs, etc.
- Plate incubation and interpretation of results.
- Microbial Identification
- Identification of isolated microorganisms from samples using biochemical or molecular methods.
- Growth Promotion Testing
- Verification of culture media performance using known control organisms.
- Environmental Monitoring
- Routine monitoring of cleanrooms or controlled environments.
- Includes scheduling, sampling, trending, and reporting.
- Plate Reading and Interpretation
- Reading, counting, and interpreting microbial growth on various types of media plates.
- Sterility Testing
- Aseptic testing to confirm that products are free of viable microorganisms.
- Familiarity with isolators or sterility test chambers.
- Endotoxin Testing
- Detection of bacterial endotoxins (e.g., LAL test).
- Use of kinetic turbidimetric or chromogenic methods.
- Compliance with cGMP and Standard Operating Procedures at all times.
- Actively contribute to continuous improvement initiatives in the lab.
- QC Micro representation at cross functional meetings.
- Providing audit support for tours and presentations as required.
- Supporting projects as required.
- Conduct duties in a safe manner and report all safety issues or concerns.
Job Type: Full-time
Pay: €30,000.00-€50,000.00 per year
Schedule:
- Monday to Friday
Application question(s):
- Understands Key Performance Indicators
- Knowledge of quality management systems (e.g. Veeva/Qualipso)
- Knowledge of lab management systems (e.g. LUNA)
Education:
- Bachelor's (required)
Experience:
- pharmaceutical : 2 years (required)
Work Location: In person
