Role & responsibilities
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.
Preferred candidate profile
- Bachelors or masters degree in chemical engineering, Pharmaceutical Engineering,
- Total experience of 8 to 12 years.
- Process engineering role of 3 to 4 years is required and experience in pharma formulations will be added advantage
- Proficiency in MS Excel, PowerPoint.
- Good communication and presentation skills
- Detail-oriented with structured problem-solving approach
Additional notes
Strong scientific knowledge about manufacturing equipment and processes in pharmaceutical formulations.