Manager
Job Description
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.
Position / Job Title
Manager – Process Engineering
Department
Technology Transfer
Reporting To
AGM, Manufacturing science and technology
Location
Ambernath
Years of Experience
Senior (8 to 12 years of experience)
Dosage Form
OSD and Nasal formulations
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.
Qualifications & Pre-Requisites
Bachelor’s or master’s 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.