SL-000356
About the client
On behalf of our client, a global leader in the pharmaceutical industry, Swisslinx is seeking for an experienced Manufacturing Engineer - MBR Design to overseeing and communicating MBR updates and requesting updates to MBRs per manufacturing changes and requirements.
- Start: July 2025 or after by arrangement
- Duration: until 31.12.2025, possible extension
- Location: Zurich (4 days/week onsite)
- Pensum: 100%, 40h/week
- Contract type: Contractor at Swisslinx
Job description
Your Mission:
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 and supports in end user training.
Validation activities:
- Support validation MES system activities IQ / OQ / PQ, write and execution protocols.
Role as 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.
Requirements
Your Profile:
- Minimum 5 year of experiences on project as an MBR / Master Batch Record Design (PAS-X 3.2) in a Life sciences/Pharma company.
- University Degree in engineering discinpline, manufacturing, supply chain or development is an advantage
- Profound experience in MES system activities (IQ / OQ / PQ), writing and executing of protocols.
- Experience in execution od MBR verification and validation activities.
- Experience in creation of the Master Data and set up object management.
- Strong team player and takes ownership and accountabilities
- Business fluent both in French and English, verbal and in written.
Online Application
If you are ready to make an impact today, we are looking forward to your online application with your latest CV. If your profile is shortlisted, our consultant will contact you for a first call to discuss the details.