Senior MES Engineer - PharmaSuite & GMP Compliance

TechDigital Group; Greenville (NC); Presencial; USD 90.000 - 140.000; Tempo integral

Resumo da vaga

TechDigital Group in North Carolina seeks a MES/FTPS developer to design, deploy, and maintain Rockwell FactoryTalk PharmaSuite (FTPS) MES applications within life sciences environments.

Responsibilities include EBR authoring to enforce manufacturing workflows, system integrations with SAP and plant‑floor SCADA, and rigorous debugging and testing prior to production.

The role requires deep GMP knowledge, SDLC discipline, 21 CFR Part 11 compliance, and working in validated environments.

Qualificações

• Experience with FTPS and MES in Life Sciences environments.
• SQL databases and RESTful API development experience.
• GMP, cGMP and 21 CFR Part 11 in validated environments.

Responsabilidades

• Develop, deploy, and maintain FTPS MES applications.
• Design, configure, and validate EBRs to enforce workflows.
• Integrate MES with ERP systems (e.g., SAP) and plant-floor systems.
• Troubleshoot defects, resolve data gaps, and perform unit testing.

Conhecimentos

Troubleshooting

Regulatory compliance

SDLC knowledge

GMP knowledge

Life sciences domain

Ferramentas

Rockwell FactoryTalk PharmaSuite (FTPS)

RESTful APIs

SQL

Descrição da vaga

Notes from HM: We have some flexibility with MES - FTPS skill set/ FactoryTalk PharmaSuite experience preferred; however, candidates with any MES experience in Life Sciences environments will be considered

• System Design & Configuration: Develop, deploy, and maintain Rockwell FactoryTalk PharmaSuite (FTPS) and FTPC MES applications.
• EBR Authoring: Design, configure, and validate Electronic Batch Records (EBR) to enforce manufacturing workflows.
• Integrations: Integrate MES solutions with ERP systems (e.g., SAP) and plant-floor control equipment/SCADA systems.
• Troubleshooting: Debug system defects, resolve data gaps, and perform unit testing before production deployments.
• Compliance: Ensure all system architectures adhere to 21 CFR Part 11, GAMP, and cGMP regulatory standards within validated environments.
Technical Requirements
• Platform Expertise: Hands-on development experience with Rockwell FactoryTalk PharmaSuite (FTPS).
• Database & APIs: Advanced SQL, database management, and RESTful API or webservices development.
• Life Sciences Domain: Deep working knowledge of Good Manufacturing Practices (GMP) and Software Development Life Cycle (SDLC) methodologies.