Seeking a driven, business and technical oriented MES Engineer within our pharmaceutical operation reporting into Digital Systems organization. The MES Engineer plays a critical role in designing, developing, validating, and maintaining electronic batch records and recipes within MES platforms. This position is responsible for managing incident queues, resolving technical issues, and supporting change control activities in alignment with quality standards and GMP regulations.
Responsibilities:
- Design, author, configure, and verify master batch records (MBRs), templates, and electronic batch records (EBRs) using MES platform (e.g. POMSnet Aquila).
- Support system integration activities, ensuring seamless data flow and interoperability between MES and other enterprise systems (such as ERP, LIMS, automation, and data management platforms via cross-functional teamwork.
- Analyze manufacturing requirements, collaborate with stakeholders (process engineers, business teams), and translate paper records into digital formats.
- Prioritize and execute support activities to align with project schedules and business needs.
- Author and maintain system and verification documentation, ensuring adherence to GMP, Global and internal quality standards.
- Demonstrate a high level of integrity and recognize the importance of quality control in pharmaceutical production.
- Perform comprehensive testing of new MES recipes and system changes.
- Troubleshoot MES issues, provide technical support during recipe execution, and resolve incidents in live production.
- Lead change management and continuous improvement initiatives to drive standardization, efficiency, and recipe optimization.
- Represent MES engineering on task forces, contribute to business projects, and influence technology strategy.
- Follow Environmental Health and Safety procedures and participate in incident investigations as required.
- Build rapport and communicate effectively with colleagues across and outside the MES team.
- Support business users, ensure their requirements are understood and delivered at or above expectations.
- The role will evolve to require Off Hours Support for MES systems.