MES Systems Manager

1 week ago

Singapore ITCAN PTE. LIMITED Full time $80,000 - $120,000 per year
Responsibilities
  • Troubleshoot and provide solutions for MES & ERP problems in recipe execution and recipe authoring.
  • Liaise with QA to provide approved change control documentation for all MES system changes.
  • Design, create, write and execute to a high-quality standard, test and validation protocols, risk assessments, and system documentation.
  • Design, create, write and/or make all required changes to MES & ERP Recipes, worksheets, equipment and material spec's including phase transition logic to a high-quality standard.
  • Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
  • Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
  • Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-around and fixes identified.
  • Work closely with IT regarding upgrades, patching, hardware support, security and system access and provide technical expertise in implementing upgrades and patching.
  • Liaise with Global MES on required system improvements.
  • Provide support to other MES system users as required to ensure business continuity.
  • Participate in MES projects from initiation to ensure MES system or hardware requirements are taken into consideration.
  • Ensure maintenance/replacement of MES hardware, printers, scales, scanners and bar-code labelers. Review for upgrades periodically.
  • Keep other MES Team Members up to date on MES changes Documentation of all activities in line with cGMP requirements.
  • Cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
  • Adheres to and supports all health and safety standards, procedures and policies.
Requirements
  • ASPEN product hands-on experience for full application configurations including interface with SAP and automation systems
  • In-depth of knowledge of pharmaceutical business process (Chemicals (W&D, Solid bulk Mfg., packaging and other unit operations), Bio Pharma processes)
  • Creation of business process flow diagram & recipe is a MUST.
  • Knowledge on Industry Standards S88 and ISA S95
  • Experience working on projects in the pharmaceutical and/or biotechnology industries knowledge of GAMP lifecycle and quality management processes employed in the pharmaceutical sector Excellent communication skills and collaborative with team members and external groups

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