Background:
Responsibilities:
- Lead the Microbiology team of 6, including management of their daily activities and support to projects and production activities
- Perform validation of microbiological methods, and sterilisation tasks
- Project support for product development, implementation of Testing and evaluation of results
- Continuous improvement of technology and policy compliance
- Ensure compliance of the monitoring of the clean room to Regulatory and Internal requirements, including trending and evaluation of results
- Adherence to the ISO and cGMP standards
Suitable candidates would typically be degree qualified to Masters or PhD level in Microbiology together with a minimum of 10 years professional experience in the medical technology or pharmaceutical sector and at least 5 years Line management experience.
- Knowledge and experience of sterilization validation tasks
- Experience with Ethylene Oxide sterilization would be an advantage
- Experience with cGMP regulations and ICH guidelines
- Team-capable, flexible and assertive personality
Fluent German and English are mandatory for these positions
For more information on this vacancy, or any other medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at a.boroky@nonstop-devices.com