The USP Expert actively participates in change controls, risk assessments, and technology trials within the manufacturing area
Job Summary
The USP Expert actively participates in change controls, risk assessments, and technology trials within the manufacturing area.
Employment in a fast growing biopharmaceutical organization with opportunities for continuous professional development and participation in specialized trainings.
The position offers real influence on process development, optimization and implementation of new technologies within a modern manufacturing environment.
Matching Summary
The USP Expert actively participates in change controls, risk assessments, and technology trials within the manufacturing area.
Skills & Requirements
Must-have
Mammalian cell culture manufacturing
Process validation and technology transfer
Manufacturing documentation management
Deviation investigations and CAPA
Single use and stainless steel technologies
Good Manufacturing Practice compliance
Nice-to-have
Cross functional team collaboration
Technical training delivery
Risk assessments and change control
Process optimization activities
Audit and inspection support
Key Requirements
Higher education in relevant scientific or technical field
At least five years of biopharmaceutical manufacturing experience
Experience with mammalian cell culture at production scale
Knowledge of upstream processing and cell banking
Experience in process validation and equipment qualification
Good knowledge of regulatory requirements for biological medicinal products