
IT Operations Manager
2 days ago
We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional expertise in manufacturing execution systems and lifecycle management. The successful candidate will be responsible for supporting the implementation of MES & L2 at our manufacturing sites.
The ideal candidate will possess a deep understanding of system functionality, configuration, and compliance requirements. They will also have experience leading site-level validation activities and managing GxP documentation related to the MES & L2 system.
In addition, the Senior Manufacturing Execution System Specialist will serve as the first point of contact for any MES front-end application issues, supporting users in troubleshooting, training, and ongoing system usage post-go-live.
About This Role- MES Implementation: Representing site-specific needs during MES design, configuration, and deployment.
- Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution.
- Documentation Ownership: Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports).
- MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture.
- Front-End Support: Acting as the first point of contact for MES application issues and user support.
- Training & Adoption: Delivering training and ensuring user readiness for MES usage.
- Data Management: Supporting data collection, migration, and master recipe creation.
- Audit Readiness: Ensuring all documentation and systems are compliant and audit-ready.
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