SME Granulation

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Job Grade:

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Job Summary

granulation processes and equipment

Area Of Responsibility

Technical Expertise

• Act as the primary expert for

  high-shear mixers/RMG, fluid-bed granulators/dryers (FBD), roller compactors, milling and blending systems

  ,

  bin handling, and closed transfer systems.

• Define and optimize critical process parameters (CPPs) and material attributes (CMAs) for consistent granule quality (PSD, LOD, porosity, flowabilityCarr Index / Hausner Ratio).

Troubleshooting & Support

• Lead resolution of chronic issues: low yield, poor granule flow, inconsistent LOD, segregation, over/under granulation, capping/chipping in downstream compression.
• Execute structured RCA (5-Why, Fishbone) and implement permanent corrective actions.

Process Optimization/Benchmarking

• Drive OEE improvement, cycle time reduction, and SMED for batch changeovers.

• Implement PAT tools (e.g., NIR moisture, torque/power trend analysis) and digital logging to stabilize batches.

Compliance & Validation

• Ensure adherence to cGMP, cleaning validation, cross-contamination control, containment (OEB levels), ATEX/dust explosion safety.
• Own equipment lifecycle: URS FAT/SAT IQ/OQ/PQ, change control, and periodic review; ensure 21 CFR Part 11 compliance for data integrity.

Training & Capability Building

• Ability to Train operators/maintenance on best practices: endpoint detection, sieving/milling, cleaning/line clearance, and safety protocols.

Vendor/OEM Management/Emerging Technologies

• Liaise with OEMs for upgrades, process audits, spares, retrofits (e.g., WIP/CIP, improved bowl designs, containment solutions).
• Candidate should have a flair to remain update on latest Trends and technologies in the field

Physical Requirements:

Technical Knowledge

• Granulation science:

  binder systems, torque/power curves, endpoint criteria, moisture profiles, PSD control, and downstream compressibility.
• Equipment qualification and validation; data integrity; cleaning validation; containment and ATEX.

• CI toolset:

  TPM, Lean, Six Sigma (Green/Black Belt preferred), SMED, Kaizen.

• Digital & Analytics:

  Comfortable with OEE dashboards, trend analysis, PAT signals, and batch data review for CPV.

• Soft Skills

  : Strong problem-solving, shop-floor presence, stakeholder influence, and vendor management.

*Work experience with Equipment manufacturers will be an added advantage

Travel Estimate

Up to 40%-50% India and Globally

Job Requirements

Educational Qualification

Bachelor’s or Master’s degree

Experience

12–15 years in pharma granulation (OSD), with hands-on exposure to wet granulation, fluid-bed drying, and roller compaction.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

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