Sr. Software Engineer

Yash Technologies; Pune District; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Flexible work arrangements

Stable employment

Ethical corporate culture

Job summary

A technology solutions provider in Pune is seeking a skilled Rockwell FactoryTalk PharmaSuite MES Engineer to design and implement Master Recipes and Electronic Batch Records in regulated pharmaceutical environments. Candidates should have over 5 years of experience, strong expertise in FactoryTalk systems, and ensure compliance with industry standards. This role emphasizes teamwork, continuous improvement, and flexible work arrangements within a supportive corporate culture.

Qualifications

• 5+ years of hands-on experience with FactoryTalk PharmaSuite in pharma or life sciences.
• Strong experience in Master Recipe development using Recipe Designer.
• Practical knowledge of recipe and workflow development in PharmaSuite MES.

Responsibilities

• Design and maintain Master Recipes using FactoryTalk PharmaSuite.
• Implement Electronic Batch Records within PharmaSuite.
• Ensure compliance with 21 CFR Part 11 and GAMP 5.

Skills

FactoryTalk PharmaSuite expertise

Master Recipe development

Batch execution workflows

GxP compliance

SQL Server knowledge

Good communication skills

Job description

At YASH, we re a cluster of the brightest stars working with cutting‑edge technologies. Our purpose is anchored in a single truth bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future.

We are looking forward to hire FactoryTalk PharmaSuite Professionals in the following areas :

Role Overview

We are looking for an experienced Rockwell FactoryTalk PharmaSuite (FTPS) MES Engineer with strong hands on expertise in Master Recipe development using Recipe Designer, recipe and workflow configuration, and Electronic Batch Record (EBR) implementation in regulated pharmaceutical manufacturing environments.

The ideal candidate will have practical experience working on PharmaSuite MES systems, supporting recipe lifecycle management, batch execution workflows, and ensuring compliance with 21 CFR Part 11 and GxP requirements.

Experience

5-6 Years

Key Responsibilities

• FactoryTalk PharmaSuite & Recipe Management
• Design, develop, and maintain Master Recipes using FactoryTalk PharmaSuite Recipe Designer.
• Configure recipe workflows, including Unit Procedures, Operations, and Phases, aligned with ISA 88 standards.
• Develop and enhance PharmaSuite MES building blocks for manufacturing and packaging processes.
• Implement and support Electronic Batch Records (EBR) within PharmaSuite.
• Manage recipe versioning, approvals, controlled deployment, and change management.
• Import and validate recipes across Development, Stage, and Production environments.
• MES Configuration & Execution
• Configure Production Execution Client, Production Management Client, and Data Manager components.
• Model equipment hierarchies (classes, entities, properties), Work Centers, and Workstations.
• Author and test material operations, including Weigh & Dispense and packaging workflows.
• Support batch execution, exception handling, and workflow optimization.
• Validation & Compliance
• Ensure MES configurations comply with 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles.
• Contribute to URS, FRS, IQ, and OQ activities related to MES and recipe workflows.
• Prepare validation evidence, test scripts, and configuration documentation.
• Support audits, inspections, and periodic reviews.
• Support & Continuous Improvement
• Troubleshoot recipe execution issues, EBR failures, and workflow deviations.
• Support PharmaSuite upgrades and regression testing of recipes and workflows.
• Collaborate with QA, Automation, Manufacturing, and IT teams.

Required Skills & Experience

• 5+ years of hands on experience with FactoryTalk PharmaSuite (FTPS) in pharma or life sciences environments.
• Strong experience in Master Recipe development using Recipe Designer.
• Practical knowledge of recipe and workflow development in PharmaSuite MES.
• Experience with EBR configuration and batch execution workflows.
• Solid understanding of ISA 88 batch standards.
• Working knowledge of 21 CFR Part 11, GxP, and data integrity requirements.
• Experience preparing or supporting IQ/OQ and validation documentation.
• Familiarity with SQL Server and MES data handling.
• Good communication and stakeholder coordination skills.

Preferred / Good to Have

• Exposure to PharmaSuite version upgrades and multi site deployments.
• Experience working in global pharma manufacturing environments.
• Understanding of integration with PLC/SCADA systems (Rockwell Automation).
• Prior audit or regulatory inspection support experience.

Our Hyperlearning workplace is grounded upon four principles

• Flexible work arrangements, Free spirit, and emotional positivity
• Agile self-determination, trust, transparency, and open collaboration
• All Support needed for the realization of business goals,
• Stable employment with a great atmosphere and ethical corporate culture