SME Granulation Engineer

About the Role

Join Sun Pharma in Mumbai as an SME Granulation Engineer, where your technical leadership will drive excellence in granulation processes and equipment including wet, dry/roller compaction, and fluid-bed systems. You'll play a key role across development, scale-up, and commercial manufacturing within all SGO sites. Sun Pharma fosters a growth-focused and collaborative workplace encouraging personal ownership and continuous improvement.

Key Responsibilities

• Serve as the subject matter expert for equipment such as high-shear mixers/RMG, fluid-bed granulators/dryers, roller compactors, milling and blending units, bin handling, and closed transfer systems.
• Define and refine critical process parameters and material characteristics to ensure consistent granule quality indicators like particle size distribution, loss on drying, porosity, and flow properties.
• Lead comprehensive troubleshooting and resolution of persistent granulation challenges, applying structured root cause analysis methods and implementing lasting corrective actions.
• Manage installation, commissioning, instrumentation, calibration, and operation of granulation machinery.
• Pursue operational excellence by enhancing Overall Equipment Effectiveness (OEE), reducing cycle times, and facilitating quick batch changeovers with SMED techniques.
• Leverage Process Analytical Technology (e.g., NIR moisture, torque/power trending) and digital data logging to stabilize production batches.
• Ensure full compliance with cGMP, cleaning validation, cross-contamination prevention, containment standards (including OEB), and ATEX regulations on dust explosion safety.
• Oversee the equipment lifecycle from User Requirement Specification (URS) through FAT/SAT and IQ/OQ/PQ processes, including periodic equipment reviews and data integrity compliance to 21 CFR Part 11.
• Train operators and maintenance personnel on best practices covering endpoint detection, size reduction, cleaning, line clearance, and safety.
• Collaborate with OEMs for equipment upgrades, auditing, spare parts management, and retrofits while keeping abreast with emerging industry technologies.
• Be physically prepared for substantial travel (up to 40-50% within India and internationally).

Required Expertise

• In-depth understanding of granulation science including binder systems, torque and power profiles, moisture control, particle size distribution, and factors influencing downstream compressibility.
• Proficient with equipment qualification, validation, cleaning protocols, containment, and compliance to ATEX safety standards.
• Knowledgeable in Continuous Improvement methodologies such as TPM, Lean, Six Sigma (Green/Black Belt preferred), SMED, and Kaizen.
• Skilled in digital analytics to interpret OEE dashboards, trend analyses, PAT tooling signals, and batch data review for continuous process verification.
• Strong problem-solving skills with excellent stakeholder engagement, vendor management aptitude, and visible leadership on the production floor.
• Experience collaborating with equipment manufacturers is advantageous.

Qualifications & Experience

Bachelor's or Master's degree is required.
12 to 15 years of experience in pharmaceutical granulation primarily in Oral Solid Dosage (OSD) formulations, including hands-on work with wet granulation, fluid-bed drying, and roller compaction processes.

Additional Information

Sun Pharma is committed to your success and well-being, offering comprehensive benefits and opportunities for both personal and professional development. This job description outlines general duties and responsibilities but may be updated or adjusted as necessary to align with organizational needs and employee expertise.