20 Sep
|
Sai Life Sciences
|
India
20 Sep
Sai Life Sciences
India
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 secure, compliant, and effective 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 recent 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.
📌 Manager Plant Process Engineering Bidar (India)
🏢 Sai Life Sciences
📍 India