Microbiology SpecialistApply Now Email Me Job ID R0004645 Date posted 09/27/2018 Location:Madrid, Spain
Purpose of the job:
Provide scientific and technical expertise in Microbiology methods, measurements and metrics as well as in aseptic processes
- Supervise microbiological laboratory data and carry out trend analysis of environmental monitoring data
- Propose and monitor implementation of appropriate corrective actions, assessment of alert levels and of overall status of bioburden control of the facility and personnel working in the facility
- Support process simulations, assess aseptic practices of personnel working in the manufacturing facility.
- Provide basic microbiology training and aseptic practices training to production personnel
- Deliver technical support to the development and execution of microbiological methods such as Microbial Enumeration, Sterility in a barrier isolator, Endotoxin, Container Closure Integrity and non-routine microbiological assays and applicable GMPs & laboratory techniques.
- Supervise maintenance/troubleshooting of laboratory equipment.
- Author microbiology SOPs and scientific & technical protocols and reports. Communicate results to QC Head and other functions as required
- Perform laboratory investigations related to Deviations, OOS, and take part in change control processes.
- Ensure accuracy & scientific soundness of Lab Data
Skills, experiences and qualifications required for the job:
- BS/BA in Microbiology, Biological Sciences, or related field of study or a combination of education & experience.
- Minimum of 5 years of experience in a clinical or industrial/pharmaceutical microbiology laboratory or other highly GMP regulated environment
- Expertise to support method development, method suitability and testing in support of the pharmaceutical industry.
- Experience and expertise to write GMP documents
- Industry experience as a microbiologist
- Kinetic/Gel Endotoxin, bioburden, Sterility testing experience
- Familiarity with Microorganism identification by DNA/RNA or related advanced techniques
- Strong project management skills
- Able to perform systematic problem solving
- Tidy, neat and organized. Attention to detail
- Must be able to work as part of a team but also have the confidence to work alone.
- Good interpersonal skills
- Flexible working attitude, open to changes for assuming new methodologies and activities.
- General experience working with computers at user level, including MS Word, MS Power point and MS Excel.