Sr. Microbiologist

at  Thermo Fisher Scientific

JOB SUMMARY

The Sr. Microbiologist is our SME on several topics and will be the go to resource within our organization for microbiological quality questions, e.g. during production, nonconforming and complaint handling.
You will succeed in the role when you support operation, product management, R/D and quality to ensure the best possible experience for our customers. As a specialist you will cover and provide daily support to a range of colleges within operational quality and production, e.g. in connection with biological method/test validation. You will have contact to all functions onsite and to some corporate specialist functions on a less frequent basis.

• Lead QA activities to optimise documentation for sterilization and surface modification
• Support development and maintenance of test-methods, sampling plans, equipment, protocols, instructions etc. using statistical techniques to ensure compliance with regulatory requirements and relevant standards
• Participate in validation and qualification of software, processes, test methods at our in-house gamma irradiation plant according to international sterilization standards
• Participating and driving of projects with focus on quality improvements or quality documentation e.g. shelf-life testing, process improvements lean and practical process improvements PPI
• Conduct and support root cause analysis during complaint handling, CAPA and NCM/OOS
• Training of other employees at the site, in relation to quality - biology related issues ensuring that we can improve the level of knowledge in general at our site