Requirements: English
Company: CK Group
Region: Neuchtel , Neuchtel
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:- 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.
- Required to attend MBR design workshops, to provide input and requirements into MBR design, and follows completion as part of the sustaining support.
- Responsible for participating in informal dry runs and execution of MBR verification activities.
- Execute test orders to dry run the MBRs and provide input, feedback and corrections to the MBR designers.
- Supports MBR Verification in creating test steps for the MBR Verification protocols, and assists in executing or executing the MBR verification protocols.
- Provides primary HyperCare for site Go-Live. - Supports end user training.
Validation Activities:- Support validation MES system activities IQ / OQ / PQ, write and execution protocols.
MBR Designer:- 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.
- Responsible for creation of the Master Data and set up object management (status diagram).
- Responsible to follow the Global MBR Design Rules.
Candidate s Requirements:- Candidate needs to have 5-years experience on projects as an MBR Designer PAS-X 3.2 in a Life sciences company.
- French & English speaking & writing is a must.
Apply: If you are interested, please send an updated CV in English or French.
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.