Jobdescription
We are currently supporting our client, an important company in the life sciences sector, in the search for a Manufacturing Engineer with expertise in MBR (Manufacturing Batch Record) design and validation activities for a project based on PAS-X 3.2.
Temporary Contract managed through Randstad
Contract Duration: 28/07/2025 – 19/12/2025 (with possible extension)
Workload: On-site presence required at least 4 days per week
Languages: Fluent French and English (spoken and written)
Main Responsibilities:
Process SME:
* Manage updates and request modifications to MBRs based on evolving manufacturing needs.
* Participate in MBR design workshops, providing technical input and ensuring alignment with operational requirements.
* Support and execute informal dry runs and formal MBR verification activities.
* Execute test orders and review MBRs, delivering feedback to the MBR design team.
* Assist in creating and executing MBR verification protocols.
* Provide HyperCare support during the MES Go-Live phase.
* Contribute to end-user training activities.
Validation Activities:
* Support MES validation activities (IQ, OQ, PQ phases), including drafting and executing validation protocols.
MBR Designer:
* Ensure that MBRs accurately document the manufacturing process and collect all necessary compliance data.
* Create Master Data and manage object status diagrams.
* Ensure strict adherence to Global MBR Design Rules.
Profile Requirements:
* A minimum of 5 years of experience as an MBR Designer on PAS-X 3.2 projects within life sciences environments.
* Excellent communication skills in French and English, both spoken and written.
* Availability to work on-site at least 4 days per week.