Key skills
Rockwell FactoryTalk PharmaSuite (FTPS)Electronic Batch Records (EBR) AuthoringERP system integrationSAPSCADA systemsSQLDatabase managementRESTful API developmentWebservices development21 CFR Part 11 complianceGAMP compliancecGMP complianceManufacturing Practices (GMP)Software Development Life Cycle (SDLC) methodologiesUnit TestingRESTfulERPSDLC
About this role
Apolis is a company seeking a Senior MES Engineer in Greenville, NC. The role involves developing and maintaining MES applications, ensuring compliance with regulatory standards, and integrating MES solutions with ERP systems.
Responsibilities:
- Develop, deploy, and maintain Rockwell FactoryTalk PharmaSuite (FTPS) and FTPC MES applications
- Design, configure, and validate Electronic Batch Records (EBR) to enforce manufacturing workflows
- Integrate MES solutions with ERP systems (e.g., SAP) and plant-floor control equipment/SCADA systems
- Debug system defects, resolve data gaps, and perform unit testing before production deployments
- Ensure all system architectures adhere to 21 CFR Part 11, GAMP, and cGMP regulatory standards within validated environments
Requirements:
- Develop, deploy, and maintain Rockwell FactoryTalk PharmaSuite (FTPS) and FTPC MES applications
- Design, configure, and validate Electronic Batch Records (EBR) to enforce manufacturing workflows
- Integrate MES solutions with ERP systems (e.g., SAP) and plant-floor control equipment/SCADA systems
- Debug system defects, resolve data gaps, and perform unit testing before production deployments
- Ensure all system architectures adhere to 21 CFR Part 11, GAMP, and cGMP regulatory standards within validated environments
- Hands-on development experience with Rockwell FactoryTalk PharmaSuite (FTPS)
- Advanced SQL, database management, and RESTful API or webservices development
- Deep working knowledge of Good Manufacturing Practices (GMP) and Software Development Life Cycle (SDLC) methodologies
- 14.00 Years of Experience
- FTPS skill set
- FactoryTalk PharmaSuite experience