Validation Expert

Fresenius Medical Care is the world's leading provider of products and services for dialysis by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day.
Our manufacturing plant in Palazzo Pignano specializes in producing bloodlines, operating around the clock with a dedicated workforce of more than 550 employees. Within this dynamic setting, our Validation Expert, part of Industrial Engineering department, plays a pivotal role, being responsible for Plant Validation, elaboration of plans, management and performing of validation activities concerning processes, facilities, equipment and computerized systems.

Tasks
Preparation of validation plans, protocols, reports and procedures of critical process and equipment;
Execution in cooperation with involved departments of equipment and process validation;
Filling in validation protocols;
Collecting information from involved departments to prepare validation documents;
Review and integration in company system protocols and reports from suppliers
Preparation of plans, protocols, reports and procedures of computer system validation;
Supporting the QA in preparation and updating Validation Master Plan;
Supporting involved departments in risk analysis of manufacturing processes;
Performing statistical data analysis.
Requirements
Scientific university degree, preferably engineering.
3 years in process validation in biomedical or pharmaceutic industry.
Knowledge of Biomedical standards, ISO standards and FDA standards (nice to have).
#J-18808-Ljbffr