The Quality Engineering Execution Systems Senior Associate is responsible for supporting the setup and structure of the automation and MES systems (Delta V and Syncade) to enable the start-up, commissioning and validation of the new Large Scale Manufacturing facility to be located at the Solothurn, Switzerland campus. This will include providing the Quality Management System input on review/approval of automation validation and engineering documents, test protocols, CAPAs, deviations, change controls and any technical documentation where Quality Assurance needs to approve before implementation and upon completion. Furthermore, this role may be an active member of automation groups/project teams in which Quality input is needed. These projects could be cross-functional in nature and may involve participation across sites as well. The Quality Engineering Senior Associate II will work in/on systems that control key functional, tactical and operational aspects within the Quality Assurance organization at the Company's Solothurn Facility.
- Maintain knowledge of relevant FDA/EMA regulations and compliance.
- Approximately 3 years of experience in pharmaceutical or biotech manufacturing environment.
- Previous experience within Quality Assurance or related function is preferred.
- Good communication skills in English, verbally and written. Technically orinented role including experience of the validation of laboratory, production equipment automation systems and knowledge of production methodology involved in biopharmaceutical production.
- Self driven, demonstrated ownership and responsibility for work assignments. Value teamwork at all levels and performs work with an open mind inviting input and feedback from partners across the organization. Ability to work with colleagues across the organization.