MES Engineer

Found in: Talent MY C2 - 6 days ago


Kuala Lumpur Metropolitan Area, Malaysia PharmEng Technology Full time

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

The Role

Your responsibilities include:

  • Responsible for execution of protocols for testing and validating electronic batch records.
  • Responsible for testing of MES systems project, which includes infrastructure setup, software installation, recipe development, and System Acceptance Testing (SAT) with users.
  • Working with MES leads, system users and process owners to develop, revise, and maintain MES recipes.
  • Responsible for creating and maintaining electronic logbooks and electronic batch records.
  • Responsible for creating and maintaining electronic batch records and configuring production recipes using object libraries.
  • The potential resource should be capable of driving the testing and deployment of Opcenter software solutions, ensuring sufficient automated testing to maintain solution quality.
  • The potential resource must have experience with Electronic Batch Record System Modeling specifically in the Siemens Opcenter platform.
  • Responsible for assisting in designing and deployment of MES systems to replace paper based or manual systems including batch records, weigh & dispense, warehouse management and material tracking in a pharmaceutical or medical device environment.
  • Actively participate in fit-gap analysis of customer requirements vs. MES system functionality.
  • Provide technical input to help troubleshoot issues during MES usage and support end-users in MES navigation, EBR execution and general system utilization to ensure users become self-sufficient.
  • Practical hands-on experience with Siemens Opcenter is required.
  • The potential resource should have experience in gathering requirements and translating them into a product vision, demonstrating expertise in development and engineering.
  • Experience in application development, testing, and support based on Software Development Life Cycle (SDLC) methodology is necessary. Demonstrated understanding of key pharmaceutical niche processes, Pharma GxP regulations, and ISA-88/ISA-95 standards is important in this role.

Ideal Profile

  • Bachelor’s Degree in Engineering/Computer Science/Integrated Manufacturing disciplines or equivalent experience.
  • Firm understanding of cGMP validation requirements / guidelines and current industry practice.
  • More than 4 years of working experience with JAVA, Oracle, C, C++and SQL.
  • More than 4 years of working experience with SAP and ERP.
  • More than 4 years of working experience with Werum PAS-X, Syncade and Aspen Tech.

What's on Offer?

  • Comprehensive benefits package & competitive wages.
  • A supportive environment where employee growth is promoted.
  • Paid holidays.
  • Other great incentives.

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