MES Engineer (Pharma)

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, process instructions, 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 supporting MES roll out or maintenance in pharmaceutical or medical device industry may apply for a Junior role.
• Have at least been a user of one 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) or have authored recipes in the MES.
• 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 some experience in system background including virtualization, software and hardware.
• Preferably with some experience with system integration such as between MES and ERP, MES with DCS and / or MES and Historian.
• Preferably with working knowledge on database management.
• 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 Intelligence, Resourcefulness, Loyalty 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.