MES Engineer (Pharma)

ORKA LIFESCIENCE PARTNERS PTE. LTD.; Singapore; On-site; SGD 60,000 - 110,000; Full time

Job summary

ORKA LIFESCIENCE PARTNERS PTE. LTD. seeks an MES specialist to design, configure and deploy MES in pharmaceutical plants, and to integrate MES with ERP, PLM and LIMS. You will develop electronic batch records, workflows, and reports, and provide end-user training and support.

You will assist in qualification/validation activities, troubleshoot issues, and contribute to system change management and continuous improvement in a regulated biopharma environment.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering or related field is required.
• At least 2 years in the pharmaceutical industry; fresh graduates with internship may apply for a Junior role.
• Experience with at least one MES (e.g., Syncade, PAS-X, OpCenter EX Pharma, POMSnet, PharmaSuite) or data management/integration tech.

Responsibilities

• Design, configure and deploy MES in pharmaceutical manufacturing plants.
• Integrate MES with ERP, PLM, LIMS via appropriate interfaces.
• Develop and maintain electronic batch records, recipes, workflows, and logs.
• Develop reports, dashboards, and visualizations for performance insights.
• Provide user training and technical support.
• Support qualification/validation activities including test scripts.
• Troubleshoot MES issues with IT and manufacturing teams.
• Support project and system change management.
• Contribute to continuous improvement and keep documentation updated.
• Identify gaps in system administration and drive improvements.

Skills

MES experience

Data visualization

System integration

Cloud platforms

Reporting tools

Database management

Virtualization

Compliance knowledge

Education

Bachelor’s degree in Life Sciences, Engineering or related field

Tools

Syncade

PAS-X

OpCenter EX Pharma

POMSnet

PharmaSuite

OSI PI

IP.21

Job description

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 experience in system background including virtualization, software and hardware.
• Preferably with 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 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 possessingIntelligence, Resourcefulness, Loyalty and Teamworkcharacteristics.
• 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.