Roles & Responsibilities
Position Overview
We are seeking a detail-oriented and proactive professional responsible for the design, development, and validation of Master Batch Records (MBRs) and associated systems. This role requires close collaboration with cross-functional teams to ensure compliant, efficient, and effective batch record solutions that integrate seamlessly with manufacturing operations and equipment.
Key Responsibilities
- Develop, configure, and test Master Batch Records (MBRs) and Parameter Value Lists (PVLs) from initial design through to final approval.
- Conduct MBR design reviews in collaboration with Operations, Process Development, and Quality teams.
- Draft, execute, and review Application Lifecycle Management (ALM) test scripts and test sets to validate MBR design.
- Design, configure, and test equipment integration to enable MBR interaction with shop floor systems (e.g., OSI PI, Recipe Managers, DeltaV).
Required Qualifications
Bachelors degree in Chemical Engineering, Biotechnology, Life Sciences, or related field.Strong hands-on experience with downstream processing operations, including understanding of process steps, critical parameters, and typical plant operations.Prior involvement in MES implementation or system validation projects (e.g., PAS-X, Siemens Opcenter) is highly preferred.Ability to independently assess MES design documents and provide process-aligned feedback.Tell employers what skills you have
MES
Test Equipment
Software Engineering
Agile
Scripting
JavaScript
Reliability
Manufacturing Operations
Biotechnology
Plant Operations
Application Lifecycle Management
Life Sciences
Chemical Engineering
Commissioning
Software Development
C++