1. Role Purpose
To provide technical support for commercial manufacturing operations by optimizing processes, improving productivity, enhancing plant capacity, supporting process validation activities, and ensuring regulatory compliance. The role acts as a bridge between R&D, Production, Engineering, QA, and EHS to facilitate successful technology transfer, process robustness, operational excellence, and continuous improvement.
2. Key Responsibilities
1.Process Optimization & Continuous Improvement
- Drive continuous improvement initiatives to enhance product quality, process efficiency, productivity, and cost effectiveness.
- Identify process bottlenecks and recommend technical solutions for performance enhancement.
- Evaluate process trends and implement improvement projects to improve yield, cycle time, and resource utilization.
- Support operational excellence initiatives across manufacturing operations.
2.Process Design & Scale-Up Support
- Design, develop, optimize, and scale up manufacturing processes from pilot/commercial scale in compliance with GMP requirements.
- Support technology transfer and scale-up activities from R&D to commercial manufacturing.
- Recommend process modifications to improve robustness, safety, and manufacturability.
- Assist in troubleshooting process-related issues during commercial production.
3.Capacity Enhancement & Debottlenecking
- Identify opportunities to increase manufacturing capacity of commercial products.
- Conduct debottlenecking studies and capacity assessments.
- Develop and implement process improvement initiatives for capacity enhancement.
- Support business requirements through efficient utilization of plant resources and infrastructure.
4.Utility Engineering Support
- Perform utility calculations and capacity assessment for manufacturing processes.
- Support sizing and selection of: Reactors, Heat Exchangers, Utility Systems, Pumps
- Process Equipment etc.
5.Process Monitoring & Performance Analysis
- Monitor critical process parameters and manufacturing performance.
- Analyze process deviations, trends, and operational challenges.
- Prepare technical evaluations and recommend corrective actions.
- Establish process performance metrics and monitor improvements.
6.Process Validation & Qualification Support
- Lead and support: Process Validation, Process Verification, Revalidation Activities, Technology Transfer Documentation etc.
- Prepare and review validation protocols and reports.
- Ensure validation activities comply with regulatory and quality requirements.
7.Safety & EHS Compliance
- Ensure safe operation of manufacturing processes and equipment.
- Support process risk assessments, HAZOP recommendations, and safety improvement initiatives.
- Comply with EHS procedures, Responsible Care requirements, and IMS standards.
Qualifications & Experience
- M. Tech/ B.E./ B. Tech in Chemical Engineering
- Certification in Process Engineering, Lean Manufacturing, Six Sigma, or GMP Compliance
- 8–10 years of experience in Technical Services, Process Engineering, Technology Transfer, Production Support, Process Development, or Manufacturing Excellence.
- Experience in Pharmaceutical, API, CDMO, Specialty Chemical, or Process Industries preferred.