We are seeking a talented MES Engineer to join our team in the Life Sciences industry. The successful candidate will collaborate closely with cross-functional teams to ensure the efficient and compliant execution of manufacturing processes.
Key Responsibilities:
- Responsibility during MES implementation phases
- Collaborate with stakeholders, including manufacturing, quality assurance, and IT teams, to gather requirements and define design specifications.
- Design and develop manufacturing workflow within the Manufacturing Execution System (MES) platform to support pharmaceutical manufacturing processes.
- Conduct testing and validation activities to verify the functionality and performance of workflow within the MES environment, in accordance with regulatory requirements.
- Provide training and support to end-users on functionality, navigation, and troubleshooting within the MES system.
- Provide Hypercare
- Responsibility during MES Operational support
- Support change control process for any changes made to MES system
- Analyze and troubleshoot any system interface issues related to MES system
- Analyze and troubleshoot any workflow design related issues
- Support development of Standard Operating Procedures for MES
- Participate in continuous improvement initiatives to optimize design processes, enhance system usability, and ensure alignment with evolving business needs and regulatory standards.
- Support MES system upgrade project.
Qualifications and Requirements:
- Bachelor’s degree in chemical engineering, Bioengineering, Computer Science, or a related field.
- Experience in designing and configuring batch record within a Manufacturing Execution System (MES), preferably using the Siemens MES OpCenter platform.
- 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)
- Excellent communication and collaboration skills, with the ability to effectively engage with cross-functional teams and stakeholders to gather requirements and drive project success.
- Ability to work independently and manage multiple projects simultaneously in a fast-paced, dynamic environment