- Set-up and maintain a risk based environmental and personnel sampling program.- Trending of environmental and personell data.- Set-up deviation reduction plan.- Responisble to be compliant with intern and external requirements and guidelines (ANNEX 1, USP, EP, ISO,...) concerning environmental monitoring.- Qualification of clean rooms and utilities.- Implementation of new sampling equipment.- Lead during significant deviations

- Lead during out-of-spec and out-of-trend investigations within the sterile department. (environmental monitoring, water, bioburden,...)- Defining corrective and preventive actions incooperation with the production department.- Coaching of aseptic behavior.- Review and approval of process changes and procedures

- Implementation and qualification of rapid micro technology. - Microbial / Analytical method technology transfers. - Experience with qualification and implementation of disinfectants. - Experience with microbial method validation of (non-)sterile products and raw materials. - Root Cause Analysis during deviations or Out of Trend results - Writing and reviewing of method validation protocols (Analytical and microbiological)