Pharma MES Engineer & Quality Specialist

ORKA LIFESCIENCE PARTNERS PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

ORKA LIFESCIENCE PARTNERS PTE. LTD. seeks an MES specialist to review and approve electronic batch records, elogs and MES-related documentation in biopharmaceutical manufacturing environments.

You will support qualification/validation activities, author test scripts, and help maintain MES recipes, workflows and dashboards. Strong knowledge of regulatory requirements (21 CFR Part 11, Annex 11) is preferred.

Qualifications

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked for at least 2 years in the pharmaceutical industry.
• Understand the manufacturing processes and equipment in the biopharmaceutical industry.
• Have technical understanding of the recipe / workflow / process instruction in one MES (e.g., Syncade, PAS-X, OpCenter EX Pharma, POMSnet, PharmaSuite).
• Preferably with Quality role experience.

Responsibilities

• Review and approve electronic batch records, worksheets and elog designed for MES implementation.
• Review and approve documentation for MES integration with ERP, PLM, LIMS and equipment.
• Support qualification/validation activities including authoring and executing test scripts.
• Participate in development and maintenance of electronic batch records, process instructions, recipes and workflows.
• Participate in development and maintenance of reports, dashboards and visualizations for manufacturing performance.
• Provide technical support and training to end-users.
• Support project and system change management.
• Contribute to continuous improvement of MES systems and processes.
• Maintain updated system documentation.
• Identify gaps in system administration, quality and compliance, and drive improvements.

Skills

MES knowledge

Documentation

Recipe authoring

Installation & troubleshooting

Validation support

Education

Bachelor’s degree in Life Sciences/Engineering

Tools

Syncade

PAS-X

OpCenter EX Pharma

POMSnet

PharmaSuite

Job description

ORKA LIFESCIENCE PARTNERS PTE. LTD. seeks an MES specialist to review and approve electronic batch records, elogs and MES-related documentation in biopharmaceutical manufacturing environments.

You will support qualification/validation activities, author test scripts, and help maintain MES recipes, workflows and dashboards. Strong knowledge of regulatory requirements (21 CFR Part 11, Annex 11) is preferred.