- 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).
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.