Beschreibung

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.