MES engineer

1 week ago

Singapore ITCAN PTE. LIMITED Full time
Roles & Responsibilities

Key Responsibilities:

  • Design, develop, configure, and maintain MES workflows and master data in POMSnet.
  • Collaborate with manufacturing, quality, and IT teams to implement new MES functionality and resolve issues.
  • Support and troubleshoot MES-related incidents and perform root cause analysis.
  • Lead or support MES-related projects, upgrades, and system validations.
  • Ensure MES compliance with cGMP, FDA regulations (21 CFR Part 11), and company SOPs.
  • Create and maintain technical documentation, user guides, and training materials.
  • Perform testing, validation (IQ/OQ/PQ), and change control procedures for MES changes.
  • Monitor MES system performance and implement improvements to enhance efficiency.
  • Participate in audits and provide technical support related to MES during inspections.

Qualifications and Requirements:

  • Bachelor's degree in Chemical Engineering, Bioengineering, Computer Science, or a related field.
  • 3 to 5 years of experience in MES solution in Life Science
  • Experience in designing and configuring batch record within a Manufacturing Execution System (MES), preferably using MES platforms such as PAS-X, OpCenter, POMSnet.
  • Strong understanding of pharmaceutical manufacturing processes, cGMP guidelines, and regulatory requirements, with knowledge of industry standards such as ISA-95.
  • Experience in conducting testing, validation, and qualification activities for MES implementations, ensuring compliance with regulatory standards.
  • Strong understanding of MES system interfaces (with ERP, DCS, PCS/PLC)
Tell employers what skills you have
MES
Technical Documentation
DCS
FDA
ERP
Manufacturing Processes
Root Cause Analysis
Compliance
Audits
Change Control
Regulatory Requirements
Manufacturing
Chemical Engineering
Technical Support

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