MES Project Specialist (Contract)

GMP TECHNOLOGIES (S) PTE LTD

Singapore

On-site

SGD 120,000 - 180,000

Full time

4 days ago
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Job summary

GMP Technologies (S) Pte Ltd seeks experts to lead MES workflow finalization, testing, and qualification. You will drive change control, CAPA implementation, and ensure documentation aligns with project requirements.

You will collaborate with Site Quality, Manufacturing, and external vendors to identify improvements and execute validated solutions, including paperless MES workflows to boost efficiency and right-first-time performance.

Qualifications

  • Familiar with pharmaceutical manufacturing processes and workflows.
  • Understanding of CSV, GMP, and change control processes.
  • Ability to create and maintain project deliverables and validation documents.
  • Experience in project management, business analysis, and stakeholder coordination.
  • Experience in a GxP environment with multiple stakeholders.

Responsibilities

  • Lead MES workflow design finalization, testing, and qualification activities.
  • Drive change management and keep documentation up to date with requirements.
  • Collaborate with internal teams and vendors to resolve MES issues and implement CAPA.
  • Partner with Site Quality and Manufacturing to identify and drive process improvements.
  • Support deployment of paperless MES workflows to improve efficiency and right-first-time execution.

Skills

GxP mindset
CSV knowledge
Change control
Cross-functional collaboration
Analytical skills
Problem solving
Communication skills

Education

Bachelor's degree in Engineering/Science/CS

Tools

SAP
DCS
ServiceNow

Job description

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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