Pharmaceutical MES Software Engineer

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 15 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 15 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.