Manufacturing Systems Expert
1 week ago
Manufacturing Systems Expert:
Singapore
About the role
Manufacturing Systems Expert
Location - Singapore
About the Role:
MES Expert providing technical expertise in support of all issues linked to electronic batch records (eBRs).
MES Expert supporting MES deployment, implementation and continuous improvement in the Manufacturing Units and providing shop floor routine technical support.
Key Responsibilities:
- Define User requirement specifications (Voice of customer)
- Design and create electronic batch files (EBR) with respect for quality, costs and deadlines
- MBR / BOM/ Recipe creation in production IT systems
- Participate in the qualification and risk assessment processes
- Propose and technically validate the choice of solutions proposed by the IT teams and Automation in collaboration with the Quality team
- Participate to the deployment of MES across the manufacturing units, runs performance qualification and validation batches (commissioning of the line) with the manufacturing units
- Responsible for the manufacturing documentation update following the implementation of electronic batch files.
- Provide training for MES users in partnership with the training team.
- Ensure followup and processing of deviations and Change Control in compliance with deadlines and applicable regulations.
- Real time shop floor troubleshooting with the implementation of appropriate immediate corrective actions.
- Ensure the transfer of information to production teams following issues or modifications having a technical, quality or HSE impact.
- Responsible for MES / MIS technical knowledge transfer to the shop floor
- Ensure the preparation of audits and inspections for related topics.
- Collaborate with process experts in the context of deviations related to MES / MIS and
- Participate to change management in close collaboration with change champion and P&O partner.
Commitment to Diversity & Inclusion:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Role Requirements
Essential Requirements:
- Minimum 5 year experience in GMP manufacturing process support role
- Management of MES/LIMS related Quality and HSE investigations on time and with the required quality
- CAPAs efficiency
- Implementation of modification requests on time and without affecting the quality, conformity or safety of products or that of employees.
- Processing of internal requests related to regulatory activities on time and with the required quality
- Success rate internal/External and GMP audits/inspections
- Contribution of MES architecture and design strategy
- Subject matter expert for MES / SAP / Historian type of production IT systems
- Develop onsite expertise (MBR design, PAS-X, OSI-PI, interface with SAP and Trackwise)
- SPOC for major trouble shooting, CAPA execution, change controls management and followup for production IT systems
Desirable Requirements:
- University degree in Science is required, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent job experience
Division
Operations
Business Unit
CONTRACT MANUFACTURING
Work Location
Singapore
Company/Legal Entity
NOV SINGAPORE PHARMA MANUFG
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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