Key Roles & Responsibilities
Process Optimization & Technology Transfer
Lead the technology transfer of recent API processes from R&D;/Pilot Plant to commercial manufacturing scales.
Optimize existing manufacturing processes to improve product yields, reduce cycle times, and minimize production costs.
Conduct mass and energy balances, process modeling, and thermodynamic calculations for various chemical reactions and unit operations.
Troubleshoot complex process deviations and implement robust Corrective and Preventive Actions (CAPAs).
Equipment & Capital Projects (CAPEX)
Design and specify process equipment including reactors, centrifuges, dryers (agitated nutsche filter dryers, spray dryers), crystallizers, and distillation columns.
Prepare technical documents such as Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs;), and equipment layouts.
Support commissioning and qualification (DQ/IQ/OQ/PQ) of recent process equipment and systems.
Safety, Compliance & Quality




Lead process safety assessments including Hazard and Operability (HAZOP) studies, Failure Mode and Effects Analysis (FMEA), and dust explosion hazards.
Ensure strict compliance with cGMP, FDA, EMA, and local regulatory requirements.
Review and draft technical documentation including Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and technology transfer reports.
Leadership & Project Management
Supervise and mentor a team of process engineers and shift executives.
Collaborate cross-functionally with R&D;, Production, Quality Assurance, EHS, and Maintenance teams to meet project timelines.
Manage project timelines and budgets for process engineering initiatives and modifications.
Preferred Candidate Profile Must have 10 to 15 years of core process engineering experience strictly within API / Bulk Drug manufacturing companies.

📌 Assistant Manager Process Engineer Pharma Api Tarapur (India)
🏢 IPCA
📍 India