MSP Lead | MSP Partnering at Aristo Group | Empowering Life Science with the Perfect Match
We are seeking a skilled and experienced Process Subject Matter Expert (SME) and MBR Designer to support Manufacturing Execution System (MES) implementation and validation activities, specifically with PAS-X 3.2. The ideal candidate will play a critical role in MBR (Master Batch Record) design, verification, validation, and go-live support within a regulated life sciences manufacturing environment.
Project title: Process SME & MBR Designer (PAS-X 3.2)
Type of employment: Payroll
Skills: Process Engineer, PAS-X, MBR
Project start: 28.07.2025
Tasks:
Process SME Responsibilities:
* Lead and manage MBR update processes in response to manufacturing changes and requirements.
* Attend and actively contribute to MBR design workshops.
* Assist in the execution and support of MBR verification activities.
* Participate in informal dry runs and test order executions, providing feedback and corrections to MBR designers.
* Collaborate in the development of test steps and support execution of MBR verification protocols.
* Provide primary HyperCare and end-user training support during site Go-Live.
* Support MES system validation (IQ, OQ, PQ), including protocol writing and execution.
MBR Designer Responsibilities:
* Ensure MBRs accurately reflect the manufacturing process and capture all necessary compliance data.
* Create and maintain Master Data and manage object status diagrams.
* Adhere to Global MBR Design Rules and best practices.
* Prepare and support all MBR verification activities.
Required Skills & Qualifications:
* Minimum 5 years of hands-on experience as an MBR Designer with PAS-X 3.2 in the life sciences industry.
* Strong knowledge of MES processes, validation activities, and regulatory compliance.
* Proficiency in both French and English, with excellent communication and documentation skills.
* Ability to work independently on site at least 4 days per week.
* Strong interpersonal and collaboration skills across cross-functional teams.
Seniority level
* Associate
Employment type
* Full-time
#J-18808-Ljbffr