Assistant Manager - Process Engineer (Pharma API)

Key Roles & Responsibilities

1. Process Optimization & Technology Transfer

• Lead the technology transfer of new 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).

2. 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 new process equipment and systems.

3. 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.

4. 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.

5. Preferred Candidate Profile

Must have 10 to 15 years of core process engineering experience strictly within API / Bulk Drug manufacturing companies.