Manufacturing Engineer.

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détails du poste

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.

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.

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