Quality Assurance Engineer
vor 2 Wochen
CSL Behring is seeking a Quality Assurance Engineer to ensure the planning, development, and execution of commissioning and qualification for CAPEX- and OPEX-projects.
This role requires a Master degree in a relevant science or engineering discipline and proven work experience in a cGxP environment.
- Develop and execute commissioning and qualification plans according to local and global procedures and standards.
- Coordinate and oversee vendor FAT/SAT, commissioning activities in collaboration with internal and external partners.
- Plan and execute PQ's including sterilization / depyrogenisation cycle development, Smoke Study, Temperature/Humidity mapping.
Requirements
- Master degree in a relevant science or engineering discipline.
- Proven work experience in a cGxP environment and/or C&Q equivalent position.
- Knowledge in sterilization / dehydrogenization is a plus.
- Excellent written German and English.
- Ability to communicate clearly and effectively.
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