Custom Software Engineer

Project Role : Custom Software Engineer

Project Role Description : Develop custom software solutions to design, code, and enhance components across systems or applications. Use modern frameworks and agile practices to deliver scalable, high-performing solutions tailored to specific business needs.

Must have skills : Manufacturing Engineering MES

Good to have skills : NA

Minimum 3 Year(s) Of Experience Is Required

Educational Qualification : 15 years full time education

Summary:

As a Pharmasuite MES Architect, you will be responsible for designing, developing template based MES recipes in Rockwell FactoryTalk PharmaSuite (FTPS) to support pharmaceutical manufacturing processes. You will collaborate with cross-functional teams to ensure efficient recipe authoring and seamless integration with automation and enterprise systems while adhering to regulatory and industry standards.

Roles & Responsibilities:

• Develop MES recipes using Rockwell FTPS, ensuring compliance with industry best practices.
• Design and implement building blocks for reusable recipe structures.
• Work closely with process engineers and manufacturing teams to map end-to-end pharmaceutical processes, with a focus on biologics.
• Ensure compliance with pharmaceutical regulations (GMP, GxP, 21 CFR Part 11).
• Participate in the full MES lifecycle, from design and validation to deployment and support.
• Perform recipe testing, troubleshooting, and validation in alignment with SDLC (Software Development Life Cycle) methodologies.
• Collaborate with DCS teams to ensure seamless MES-DCS integration for automated manufacturing.
• Support and maintain MES systems in a validated state, ensuring high availability and performance.
• Provide technical expertise in MES implementation and contribute to continuous improvements in manufacturing processes.
  
  

Must-Have Skills:

• MES experience in life sciences manufacturing, specifically with Rockwell FTPS.
• Hands-on experience in MES-DCS integration for process automation.
• Knowledge of ERP and Data Historian integration with MES.
• Hands-on experience in recipe authoring, building block development, and validation.
• Strong understanding of pharmaceutical manufacturing, especially biologics.
  
  

Professional & Technical Skills:

• Knowledge of SDLC and pharmaceutical regulations (GMP, GxP, 21 CFR Part 11).
• Experience in executing at least one full MES lifecycle project with demonstrated results.
• Good communication skills to collaborate with cross-functional teams.
  
  

Additional Information:

• Minimum 3 years of experience in MES recipe design and deployment in pharmaceutical manufacturing.
• A full-time 15 years of education is required.
• This position is based out of multiple locations., 15 years full time education