Key Responsibilities:
- Design, develop, configure, and maintain MES workflows and master data in POMSnet.
- Collaborate with manufacturing, quality, and IT teams to implement new MES functionality and resolve issues.
- Support and troubleshoot MES-related incidents and perform root cause analysis.
- Lead or support MES-related projects, upgrades, and system validations.
- Ensure MES compliance with cGMP, FDA regulations (21 CFR Part 11), and company SOPs.
- Create and maintain technical documentation, user guides, and training materials.
- Perform testing, validation (IQ/OQ/PQ), and change control procedures for MES changes.
- Monitor MES system performance and implement improvements to enhance efficiency.
- Participate in audits and provide technical support related to MES during inspections.
Qualifications and Requirements:
- Bachelor's degree in Chemical Engineering, Bioengineering, Computer Science, or a related field.
- 3 to 5 years of experience in MES solution in Life Science
- Experience in designing and configuring batch record within a Manufacturing Execution System (MES), preferably using MES platforms such as PAS-X, OpCenter, POMSnet.
- Strong understanding of pharmaceutical manufacturing processes, cGMP guidelines, and regulatory requirements, with knowledge of industry standards such as ISA-95.
- Experience in conducting testing, validation, and qualification activities for MES implementations, ensuring compliance with regulatory standards.
- Strong understanding of MES system interfaces (with ERP, DCS, PCS/PLC)
