Qualification / Validation Expert (Department QC Microbiology) (m/f)

REFERENZNUMMER:

347213/11

IHRE AUFGABEN:

-Qualification/validation tasks for a new isolator for sterility testing
-Hands-on engineering tasks in the isolator qualification/validation
-Counterpart to external engineering project leader
-Coordination and attendance of relevant project meetings (represents user-group)
-Qualification of different smaller technical projects e.g. monitoring systems, filter integrity test device, glove testing devices
-Coordination and attendance of relevant project meetings
-Hands-on qualification/validation tasks
-Author of technical SOPs and Author of URS
-Technical risk assessments, change management tasks, support of maintenance tasks
-Trouble shouting regarding technical challenges in Sterilab

IHRE QUALIFIKATIONEN:

-Master in Engineering or higher automation education
-Relevant industrial experience, ideally background on sterility laboratory isolator technology before
-Experience in regulative compliance
-Advanced GMP documentation skills are a must
-Intermediate German and English levels are required

WEITERE QUALIFIKATIONEN:

Quality manager, Qualification/validation specialist