Process Engineering Manager

Purpose: The Manager Process Engineering is responsible for leading process design, optimization, scale-up, technology transfer, troubleshooting, and continuous improvement initiatives with scientific way within a pharmaceutical formulation manufacturing facility. He is responsible for overseeing and optimizing pharmaceutical formulation manufacturing processes to ensure efficiency, compliance, quality, and cost-effectiveness.

Job Responsibilities / Deliverables:

1. Process Design & Optimization in a scientific way
   Design, review, and optimize manufacturing processes for oral solids and nasal formulations.
   Lead scale-up of pharmaceutical formulations from R&D to commercial production with the scientific rational.
   Lead scale-up of pharmaceutical formulations from pilot scale to commercial production scale
   Optimize processes to reduce wastage and improve yield in manufacturing and packing operations of OSD and Nasal formulations.
   Optimize processes to reduce cycle time and minimize deviations.
   Conduct process capability studies and implement statistical process control (SPC).
   Evaluate and implement new technologies and equipment for process enhancement.
   Application of equipment know how to develop better process.
2. Troubleshooting & Technical Support
   Provide technical support to production during critical issues.
   Investigate process failures and implement corrective actions.
   Analyse trends and recommend preventive measures.
   Develop an expertise in all equipment used in manufacturing and packing operations. and train other people for the same.
3. Documentation
   Perform quality risk management of the process
   Review batch records to finalize and approve manufacturing process
   Review validation protocols and reports of the intended process.
   Handle change control, deviation investigations, and CAPA implementation
4. Training and Development
   Develop training plans and technical competency programs.
   Train production and other technical staff on equipment know how
   Train production and other technical staff on manufacturing processes.