Job Summary
We are seeking an experienced Process Engineering professional to lead process engineering activities for commercial API manufacturing. The incumbent will be responsible for process optimization, scale-up validation, debottlenecking, yield improvement, technology transfer support, troubleshooting, process capability enhancement, and cross-functional coordination to ensure safe, compliant, and efficient plant operations.
Key Responsibilities
- Lead the Process Engineering function to achieve production targets as per customer and business requirements.
- Coordinate with Production, Engineering, QC, QA, R&D, SCM, PPIC, Projects, and other cross-functional teams.
- Drive compliance with Safety, cGMP, Quality, and Environmental requirements.
- Lead and develop the Process Engineering team through training, mentoring, and capability building.
- Evaluate scale-up parameters and support process validation and commercial manufacturing activities.
- Review and approve technical documents including BPR, Change Controls, Risk Assessments, P&IDs, PSSR, Campaign Reports, and Process Evaluation Reports.
- Drive process performance metrics, including:
- Yield Improvement
- Batch Cycle Time Reduction
- Batch Charging Frequency
- Productivity Enhancement
- Conduct debottlenecking studies and capacity enhancement projects.
- Provide technical support for process troubleshooting, deviation investigations, OOS investigations, and CAPA implementation.
- Generate process trend data and present insights to cross-functional teams for continuous improvement.
- Drive cost-saving initiatives through:
- Solvent Recovery & Recycling
- Yield Improvement Projects
- Process Intensification
- Utility Optimization
- Support facility expansion, capacity enhancement, CapEx evaluation, and new product introductions.
- Evaluate utility requirements and improve resource utilization.
- Participate in customer audits, regulatory inspections, and client technical discussions.
- Support technology transfer activities and assess facility readiness for commercialization.
- Review process readiness related to Safety, Quality, Yield, Utilities, Waste Management, and Operability before campaign execution.
- Monitor critical process parameters, product quality attributes, and batch performance.
- Identify and implement new technologies and best practices for process improvement and operational excellence.