Systems Optimization Expert

6 days ago

Singapore beBeeManufacturing Full time $120,000 - $150,000
Manufacturing Execution Systems Specialist Job Opening

A challenging role for a highly skilled Manufacturing Execution Systems specialist is available in our organization. The right candidate will be responsible for designing, developing, and maintaining manufacturing execution systems in our production facility.

Key Responsibilities:

  • Develop and configure MES workflows and master data in POMSnet to optimize system performance.
  • Collaborate with cross-functional teams to implement new MES functionality and resolve technical issues efficiently.
  • Provide timely support and troubleshooting for MES-related incidents, conduct root cause analysis, and implement corrective actions.
  • Lead or support MES-related projects, upgrades, and system validations to ensure seamless integration and compliance with regulatory requirements.
  • Ensure MES compliance with cGMP, FDA regulations (21 CFR Part 11), and company SOPs by implementing quality controls and monitoring system performance.
  • Create and maintain detailed technical documentation, user guides, and training materials to facilitate knowledge sharing and skills transfer.
  • Perform thorough testing, validation (IQ/OQ/PQ), and change control procedures for MES changes to guarantee system reliability and integrity.
  • Monitor MES system performance, identify areas for improvement, and implement enhancements to optimize efficiency.
  • Participate in audits and provide technical support related to MES during inspections to demonstrate compliance with industry standards.

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 implementation in Life Science.
  • Experience in designing and configuring batch records within a Manufacturing Execution System (MES) using platforms like 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 to ensure compliance with regulatory standards.
  • Strong understanding of MES system interfaces with ERP, DCS, PCS/PLC systems.

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