On behalf of our client, a global leader in the pharmaceutical industry, Swisslinx is seeking an experienced Manufacturing Engineer - MBR Design to oversee and communicate MBR updates and request updates to MBRs based on manufacturing changes and requirements.
* Start: July 2025 or later by arrangement
* Duration: until 31.12.2025, with possible extension
* Location: Neuchâtel (4 days/week onsite)
* Full-time: 100%, 40h/week
Your Mission:
Process SME:
* Oversee and communicate MBR updates, request updates based on manufacturing changes, and assist during MBR verification activities.
* Attend MBR design workshops to provide input and requirements, and follow through to completion as part of sustaining support.
* Participate in dry runs and execute MBR verification activities.
* Conduct test runs of MBRs, providing feedback and corrections to designers.
* Support MBR verification by creating test steps for protocols and assisting in execution.
* Provide primary HyperCare during site Go-Live and support end-user training.
Validation Activities:
* Support validation of MES systems (IQ/OQ/PQ), including writing and executing protocols.
Role as MBR Designer:
* Ensure the MBR accurately reflects the manufacturing process and includes all necessary data points for compliance.
* Create master data and manage setup objects (status diagrams).
* Follow global MBR design rules.
Requirements
Your Profile:
* Minimum 5 years of experience in MBR / Master Batch Record Design (PAS-X 3.2) within the life sciences/pharma industry.
* University degree in engineering, manufacturing, supply chain, or related fields is advantageous.
* Profound experience with MES system activities (IQ/OQ/PQ), including protocol writing and execution.
* Experience in executing MBR verification and validation activities.
* Experience in creating master data and managing setup objects.
* Strong team player, taking ownership and accountability.
* Fluent in both French and English, verbally and in writing.
Online Application
If you are ready to make an impact today, we look forward to receiving your latest CV via our online application. If shortlisted, our consultant will contact you for an initial discussion.
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