SME Granulation (Engineering)

SUN PHARMA; Mumbai; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Sun Pharma in Mumbai seeks a SME Granulation (Engineering) to provide technical leadership for granulation processes and equipment across development, scale‑up, and commercial manufacturing.

You will define CPPs/CMAs, optimize processes, and ensure cGMP compliance while collaborating with cross‑functional teams. Travel up to 40–50% as required.

Requires 12–15 years of pharma granulation experience and hands‑on expertise with wet granulation, fluid‑bed drying, and roller compaction.

Qualifications

• 12–15 years in pharma granulation (OSD) with hands‑on exposure to wet granulation, fluid‑bed drying, and roller compaction.
• Experience with CPPs/CMAs and PAT tools is a plus.
• Strong problem‑solving, shop‑floor presence, and stakeholder management.

Responsibilities

• Provide technical leadership for granulation processes and equipment (wet, dry/roller compaction, and fluid‑bed systems) across development, scale‑up, and commercial manufacturing & operations at all sites of SGO.
• Define and optimize CPPs and CMAs for consistent granule quality (PSD, LOD, porosity, flowability).
• Drive OEE improvement, cycle time reduction, and SMED for batch changeovers; implement PAT tools and digital logging.
• Own equipment lifecycle: URS → FAT/SAT → IQ/OQ/PQ, change control, and data integrity compliance (21 CFR Part 11).
• Train operators/maintenance on best practices and collaborate with OEMs for upgrades and retrofits.

Skills

Granulation science

Troubleshooting

Process optimization

Equipment qualification

Education

Bachelor's or Master's degree

Job description

Key Responsibilities

At Sun Pharma, we commit to helping you “

Title

SME Granulation (Engineering)

Location

Mumbai

Key Responsibilities

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self‑drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Description

Job Summary

Provide technical leadership for granulation processes and equipment (wet, dry/roller compaction, and fluid‑bed systems), ensuring robust, compliant, and efficient operations across development, scale‑up, and commercial manufacturing & operations at all sites of SGO.

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, flowability—Carr 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.
• Should be able to handle troubleshooting and problem‑solving, acting as the primary authority for resolving complex production issues, machine malfunctions, and deviations that arise during the granulation process.
• Should have capability for installation and commissioning of granulation equipment.
• Should have knowledge about instrumentation, calibration, and operation of components installed on granulation machines.

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

Physically fit for extensive Travel

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!

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).