MES Engineer

Key Responsibilities:

• Design, configure and deploy MES in the pharmaceutical manufacturing plants.
  
  
• Integrate the MES system with other enterprise systems (e.g., ERP, PLM, LIMS) using appropriate integration methods.
  
  
• Develop and maintain electronic batch record, recipes, workflows, electronic logbooks, etc.
  
  
• Develop and maintain reports, dashboards, and visualizations to provide insights into manufacturing performance.
  
  
• Provide technical support and training to end-users.
  
  
• Support qualification / validation activities including authoring and executing test scripts.
  
  
• Troubleshoot and resolve MES system issues, working closely with other stakeholders such as IT and manufacturing teams.
  
  
• Support project and system change management.
  
  
• Contribute to the continuous improvement of the MES system and related processes.
  
  
• Maintain updated system documentations.
  Identify gaps in system administration, management, quality and compliance, and drive operational improvement processes.
  
  

Requirements:

• Hold Bachelor's degree in Life Sciences, Engineering or related field.
  
  
• Have worked for at least 2 years in the pharmaceutical industry.
  
  Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
  
  
• Have experience in one or more Manufacturing Execution System (MES) (e.g., Syncade, PAS-X, OpCenter EX Pharma, POMSnet, PharmaSuite) and/or Data management or integration technologies (e.g., OSI PI, IP.21).
  
  
• Have experience in system background including virtualization, software and hardware.
  
  
• Have experience with system integration such as between MES and ERP, MES with DCS and / or MES and Historian.
  
  
• Have working knowledge on database management.
  
  
• Preferably with understanding of manufacturing processes and equipment in the biopharmaceutical industry.
  
  
• Preferably having supported installation, administration and troubleshooting of computer systems and servers.
  
  
• Preferably with familiarity with cloud platforms.
  
  
• Preferably with reporting and data visualization tools.
  Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISA 88, GAMP5).
  
  

Why Join Orka:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
  
  
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
  
  Exposure with mutliple MES solutions.
  
  
• Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
  
  
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.