Manufacturing Engineer MBR Designer
CK QLS are looking for an experienced engineer, with background in MBR design, ideally for the life sciences industry. You will be joining a Global Pharmaceutical company, based in Neuchatel.
Duration: Until 19th December 2025, possibility for an extension.
Home office: 1 day home office a week.
Responsibilities:
Process SME:
1. Responsible for overseeing and communicating MBR updates and requesting updates to MBRs per manufacturing changes and requirements. In addition, assisting during the execution of MBR verification activities.
2. Required to attend MBR design workshops, to provide input and requirements into MBR design, and follows completion as part of the sustaining support.
3. Responsible for participating in informal dry runs and execution of MBR verification activities.
4. Execute test orders to dry run the MBRs and provide input, feedback and corrections to the MBR designers.
5. Supports MBR Verification in creating test steps for the MBR Verification protocols, and assists in executing or executing the MBR verification protocols.
6. Provides primary HyperCare for site Go-Live. - Supports end user training.
Validation Activities:
7. Support validation MES system activities IQ / OQ / PQ, write and execution protocols.
MBR Designer:
8. Responsible for assuring that the MBR reflects the manufacturing process, and all data points needed to document compliant manufacturing are gathered. As well as preparing and supporting MBR verification activities.
9. Responsible for creation of the Master Data and set up object management (status diagram).
10. Responsible to follow the Global MBR Design Rules.
Candidate’s Requirements:
11. Candidate needs to have 5-years’ experience on projects as an MBR Designer PAS-X 3.2 in a Life sciences company.
12. French & English speaking & writing is a must.