MES Project Specialist

1 day ago

singapore GMP TECHNOLOGIES (S) PTE LTD Full-time
Responsibilities
  • Lead the finalization of MES workflow designs, including design modifications, testing, change control implementation, and Operational and Performance Qualification (OQ/PQ).
  • Drive business change management activities, ensuring timely updates to design documentation and compliance with project requirements.
  • Collaborate with internal stakeholders and external vendors to identify, investigate, and resolve MES application issues, implementing effective corrective and preventive actions (CAPA) to minimize recurrence.
  • Partner with Site Quality and Manufacturing teams to identify process improvement opportunities and implement solutions within the agreed project scope, budget, and timeline.
  • Support the development and implementation of paperless MES workflows to enhance manufacturing efficiency, operational performance, and right-first-time execution.
Qualifications
  • Working knowledge of pharmaceutical manufacturing processes, operations, and associated workflows.
  • Good understanding of Computer System Validation (CSV), Good Manufacturing Practice (GMP), and change control processes.
  • Ability to develop and maintain technical documentation, including project deliverables, functional specifications, and validation documents.
  • Experience in project management, business analysis, and stakeholder coordination.
  • Experience working in a GxP-regulated environment within a matrix organization, managing multiple stakeholders across different functions.
  • Proven ability to collaborate with cross-functional business teams to identify improvement opportunities and deliver value-driven solutions.
  • Strong communication, analytical, and problem-solving skills, with a proactive approach to learning and adopting new technologies.
  • Familiarity with SAP, Distributed Control Systems (DCS), ServiceNow, and other manufacturing applications.
  • Bachelor's degree in Engineering, Science, Computer Science, or a related discipline.
  • 1-5 years of experience in manufacturing application support, consulting, implementation, or development.
  • Experience participating in or independently leading the implementation, enhancement, or deployment of manufacturing applications .
  • Demonstrated ability to analyze complex operational challenges, identify root causes, and implement effective process improvements.
  • Strong ownership, accountability, adaptability, and commitment to delivering high-quality results.
  • Demonstrates high-performance behaviours, including collaboration, continuous improvement, and a results-oriented mindset.

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